HET COLLEGE VOOR DE TOELATING VAN ......van deel A van het registratierapport. 1.4 Aflever- en opgebruiktermijn (respijtperiode) Niet van toepassing. Het betreft een nieuwe toelating

Benevia Part A

National addendum – Field - The Netherlands

15569 N

Registration Report – Central zone Page 1 of 66

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT

Op 30 april 2015 is van

FMC Operational Netherlands B.V.

Prins Bernhardplein 200

1097 JB Amsterdam

een aanvraag tot nationale toelating van een gewasbeschermingsmiddel (NL=CMS) ontvangen als

bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het

gewasbeschermingsmiddel

Benevia

op basis van de werkzame stof cyantraniliprole. Nederland is in deze een betrokken lidstaat, als

bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is het Verenigd Koninkrijk.

HET COLLEGE BESLUIT tot toelating van bovenstaand middel.

Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel

van dit besluit.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als

waarvoor de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en

zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende

aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden

vermeld:

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� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder

“verpakkingsinformatie” in bijlage I.

� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel

A van het registratierapport, Appendix I.

� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

� De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de

voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2

van deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Niet van toepassing. Het betreft een nieuwe toelating.

2. WETTELIJKE GRONDSLAG

Besluit artikel 28 en artikel 36, derde lid, van de Verordening (EG)

1107/2009

Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009

Gebruikt toetsingskader Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual Zonaal

2.0

3. BEOORDELINGEN

3.1 Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en

ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn

bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het

middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar

geacht.

3.2 Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die

vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd

gebruik.

3.3 Risico voor de mens

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het

werkzaam is.

Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het

Registration Report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit

beleidsregel bekendmaken delen A en B van het Registration Report.

Benevia Part A


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Bezwaarmogelijkheid

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de

Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes

weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College

voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.

Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift

opengesteld.

Ede, 26 april 2018

Het College voor de toelating van

gewasbeschermingsmiddelen en biociden,

voor deze:

de voorzitter,

Ir. J.F. de Leeuw

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BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20150820 NLTG

Type aanvraag: aanvraag tot nationale toelating

gewasbeschermingsmiddel (NL=CMS)

Middelnaam: Benevia

Verzenddatum aanvraag: 16 april 2015

Formele registratiedatum: * 4 juni 2015

Datum in behandeling name: 11 september 2017

Datum compliance check: n.v.t.

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.

Aangezien Benevia een voor Nederland nieuwe werkzame stof bevat (cyantraniliprole, zie

hieronder), is de zienswijzeprocedure zoals bedoeld in artikel 2:3 Besluit bestuursreglement regeling

toelating gewasbeschermingsmiddelen en biociden Ctgb 2007 toegepast. Er zijn geen zienswijzen

ontvangen binnen de daarvoor gestelde termijn.

2.2 Stofinformatie

Werkzame stof Gehalte

cyantraniliprole 100 g/L

• De stof is per 14 september 2016 goedgekeurd volgens Verordening (EU) 1107/2009

(Uitvoeringsverordening (EU) 2016/1414 d.d. 24 augustus 2016). De goedkeuring van deze

werkzame stof expireert op 14 september 2026.

2.3 Toelatingsinformatie

Toelatingsnummer: 15569 N

Expiratiedatum: 14 september 2027

Afgeleide parallel of origineel: Origineel

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel

Gebruikers: Professioneel

2.4 Verpakkingsinformatie

Aard van het preparaat:

Olie dispersie

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel Benevia

Professioneel gebruik

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:

-

Pictogram GHS07

GHS09

Signaalwoord Waarschuwing

Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken.

H410 Zeer giftig voor in het water levende organismen, met langdurige

gevolgen.

Voorzorgsmaatregelen P261 Inademing van stof/rook/gas/nevel/damp/spuitnevel vermijden.

P272 Verontreinigde werkkleding mag de werkruimte niet verlaten.

P280 Beschermende handschoenen/beschermende

kleding/oogbescherming/gelaatsbescherming dragen.

P302 + P352 BIJ CONTACT MET DE HUID: Met veel water/... wassen.

P333 + P313 Bij huidirritatie of uitslag: een arts raadplegen.

P321 Specifieke behandeling vereist (zie ... op dit etiket).

P362 + P364 Verontreinigde kleding uittrekken en wassen alvorens

deze opnieuw te gebruiken.

P391 Gelekte/gemorste stof opruimen.

P501 Inhoud/verpakking afvoeren naar ....

SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water

verontreinigt.

Aanvullende

etiketelementen

EUH401 Volg de gebruiksaanwijzing om gevaar voor de

menselijke gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Nee

Voelbare gevaarsaanduiding verplicht Nee

Benevia Part A


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REGISTRATION REPORT

PART A

RISK MANAGEMENT

PRODUCT CODE: BENEVIA

OIL DISPERSION FORMULATION

ACTIVE SUBSTANCE: CYANTRANILIPROLE 100 g/L

CENTRAL ZONE

ZONAL RAPPORTEUR MEMBER STATE: UNITED KINGDOM

NATIONAL ADDENDUM – FIELD – THE NETHERLANDS

APPLICANT: FMC OPERATIONAL NETHERLANDS B.V.

DATE: FEBRUARY 2018

EVALUATOR: CTGB, NL

Benevia Part A


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TABLE OF CONTENTS

Table of Contents ........................................................................................................................................... 7

Table of Tables ......................................................................................... Fout! Bladwijzer niet gedefinieerd.

PART A – Risk Management ....................................................................................................................... 9

1 Details of the application ............................................................................................................. 9

1.1 Application background ......................................................................................................... 9

1.2 Active substance approval ...................................................................................................... 9

1.3 Regulatory approach ............................................................................................................... 9

1.4 Data protection claims ............................................................................................................ 9

1.5 Letters of access ................................................................................................................... 10

2 Details of the authorisation ....................................................................................................... 10

2.1 Product identity .................................................................................................................... 10

2.2 Classification and labelling .................................................................................................. 10

2.2.1 Classification and labelling according to CLP .............................................................. 10

2.2.2 R and S phrases under Directive 2003/82/EC (Annex IV and V)Fout! Bladwijzer niet gedefinieerd.

2.2.3 Other phrases .......................................................... Fout! Bladwijzer niet gedefinieerd.

2.3 Product Uses ......................................................................................................................... 12

3 Risk Management ...................................................................................................................... 14

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform

Principles .............................................................................................................................. 14

3.1.1 Physical and chemical properties (Part B, Section 1, Points IIIA 2.0 and

IIIA 4.0) ......................................................................................................................... 14

3.1.2 Methods of analysis (Part B, Section 2, Point IIIA 5.0) ................................................ 14 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point IIIA 5.2) ............ 14 3.1.2.2 Analytical method for residues (Part B, Section 2, Points IIIA 5.3 to

IIIA 5.8) ................................................................................................................. 17

3.1.3 Mammalian Toxicology (Part B, Section 3, Point IIIA 7.0) .......................................... 17 3.1.3.1 Acute Toxicity (Part B, Section 3, Point IIIA 7.1) ................................................. 17 3.1.3.2 Operator Exposure (Part B, Section 3, Point IIIA 7.3) ........................................... 17 3.1.3.3 Bystander and Resident Exposure (Part B, Section 3, Point IIIA 7.4) ................... 17 3.1.3.4 Worker Exposure (Part B, Section 3, Point IIIA 7.5) ............................................. 17

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point IIIA 8.0) .......................... 18 3.1.4.1 Residues (Part B, Section 4, Points IIIA 8.3 and 8.7) ............................................ 18 3.1.4.2 Consumer exposure (Part B, Section 4, Point IIIA 8.10) ....................................... 19

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point IIIA 9.0) .......................... 19 3.1.5.1 Predicted environmental concentration in soil (PECsoil) (Part B, Section 5,

Points IIIA 9.4 and IIIA 9.5) .................................................................................. 19 3.1.5.2 Predicted environmental concentration in ground water (PECgw) (Part B,

Section 5, Point IIIA 9.6) ....................................................................................... 19 3.1.5.3 Predicted environmental concentration in surface water (PECsw) (Part B,

Section 5, Points IIIA 9.7 and IIIA 9.8) ................................................................. 21 3.1.5.4 Predicted Environmental Concentration in Air (PECair) (Part B, Section 5,

Point IIIA 9.9) ........................................................................................................ 22

3.1.6 Ecotoxicology (Part B, Section 6, Point IIIA 10.0) ....................................................... 23

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3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points IIIA 10.1 and

IIIA 10.3) ............................................................................................................... 23 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point IIIA 10.2) ............................ 23 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points IIIA

10.4 and IIIA 10.5) ................................................................................................. 24 3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6,

Point IIIA 10.6) ...................................................................................................... 25 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point IIIA 10.6) ............ 25 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point

IIIA 10.7) ............................................................................................................... 25 3.1.6.7 Assessment of Potential for Effects on Other Non-Target Organisms (Flora

and Fauna) (Part B, Section 6, Point IIIA 10.8) ..................................................... 26

3.1.7 Efficacy (Part B, Section 7, Point IIIA 6.0)................................................................... 27

3.2 Conclusions .......................................................................................................................... 32

3.3 Substances of concern for national monitoring .................................................................... 32

3.4 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation ............................................... 32

Appendix 1 Copy of the WG ................................................................ Fout! Bladwijzer niet gedefinieerd.

Appendix 2 Data Protection Claims in the Netherlands ....................................................................... 39

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PART A – RISK MANAGEMENT

This document is a national assessment containing information specific to the Netherlands.

This document describes the acceptable use conditions required for the first authorization of Benevia containing

the new active substance cyantraniliprole in the Netherlands. The active substance cyantraniliprole was

approved under Reg. (EC) No. 1107/2009 on 14/09/2016, expiring on 14/09/2026 (Reg. (EU) 2016/1414).

Benevia (cyantraniliprole 100 g/L OD) was a representative formulation reviewed during the review for active

substance approval.

Information on the detailed composition of Benevia can be found in the confidential dossier of this submission

(Registration Report - Part C).

The risk assessment conclusions on cyantraniliprole are based on the information, data and assessments

provided in Benevia Registration Report, Part B, Sections 1-8 and Part C, and where appropriate the national

addenda prepared to address country-specific risk assessment requirements for the Netherlands. The

information, data, and assessments provided in Benevia Registration Report, Part B, Sections 1-8 include

assessment of further data that has not been considered in the EU review. Otherwise, assessments for the safe

use of Benevia have been made using the EFSA Conclusion on the peer review of the pesticide risk assessment

of the active substance cyantraniliprole as published in the EFSA Journal 2014, 12 (9):3814.

1 DETAILS OF THE APPLICATION

1.1 Application background

The Registration Report is being submitted to support the first approval of Benevia containing the new active

substance cyantraniliprole. The active substance cyantraniliprole was approved under Reg. (EC) No. 1107/2009

on 14/09/2016, expiring on 14/09/2026 (Reg. (EU) 2016/1414).

The United Kingdom acted as Rapporteur for the Central Zone. All other countries in the Central Zone,

including the Netherlands, were concerned Member States.

1.2 Active substance approval

The active substance cyantraniliprole was approved under Reg. (EC) No. 1107/2009 on 14/09/2016, expiring on

14/09/2026 (Reg. (EU) 2016/1414).

Benevia was a representative formulation reviewed during the review for active substance approval. The United

Kingdom acted as the Rapporteur Member State and France as the Co-RMS.

1.3 Regulatory approach

This Benevia application was based on the agreed endpoints in the RR. The assessments are prepared per the

Uniform Principles, using RR agreed end-points.

1.4 Data protection claims

FMC Operational Netherlands B.V. claims protection of data on the active substance and the plant protection

product supporting the application for the authorisation of Benevia per the provisions set in Articles 33.4, 59 and

(where applicable) 80.2.

Studies for which data protection is claimed are identified in the list of data submitted in support of the

evaluation in Appendix 1 of each Part B Section of the Core assessment and in Appendix 2 of this country

specific Part A document.

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Appendix 2 of this document contains data protection claims for the Netherlands.

1.5 Letters of access

The data on cyantraniliprole and Benevia are owned by FMC, no LoA is required.

2 DETAILS OF THE AUTHORISATION

2.1 Product identity

Product Name Benevia (Cyantraniliprole 100 g/L OD)

Authorisation Number (for re-registration) n/a

Function Insecticide

Applicant FMC Operational Netherlands B.V.

Composition 100 g/L of cyantraniliprole

Formulation type Oil Dispersion - OD

Packaging 50-5000 mL COEX-HDPE/EVOH (High Density Polyethylene

co-extruded with ethylene vinyl alcohol copolymer) bottles

2.2 Classification and labelling

2.2.1 Classification and labelling according to CLP

The following is proposed in accordance with Regulation (EU) 1272/2008:

The identity of all substances in the mixture that contribute to the classification of the mixture *:

-

Pictogram: GHS07 Signal word: Warning

GHS09

H-statements: H317 May cause an allergic skin reaction.

H410 Very toxic to aquatic life with long lasting effects.

P-statements: P261 Avoid breathing dust/fume/gas/mist/vapours/spray.

P272 Contaminated work clothing should not be allowed out

of the workplace.

P280 Wear protective gloves/protective clothing/eye

protection/face protection.

P302+P352 IF ON SKIN: Wash with plenty of water/...

P333+P313 If skin irritation or rash occurs: Get medical

advice/attention.

P321 Specific treatment (see … on this label).

P362+P364 Take off contaminated clothing and wash it before

reuse.

P391 Collect spillage.

P501 Dispose of contents/container to ....

Supplemental Hazard

information:

EUH401 To avoid risks to human health and the environment,

comply with the instructions for use.

SP1 Do not contaminate water with the product or its

container.

Child-resistant fastening obligatory? not applicable

Tactile warning of danger obligatory? not applicable

Explanation:

Pictogram: -

H-statements: -

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P-statements: -

Other: -

* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

Benevia Part A

National addendumt – Field - The Netherlands

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2.3 Authorised uses

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-No.

Member state(s)

Crop and/ or situation

F G or I

Pests or Group of pests controlled

Application Application rate per treatment

PHI (days)

Remarks:

a) max. no. of applications per crop and season

b) Maximum product rate per season

c) additional remarks

Method / Kind

Timing / Growth stage of crop & season

Number / (min. Interval between applications)

kg, L product / ha

g, kg as/ha

Water L/ha min / max

1 NL Potato F Coleoptera: Leptinotarsa decemlineata

hydraulic ground directed boom

BBCH 12-70

(May-Aug)

2 (7 days) 0.125 L/ha

12.5 g/ha

300-600 14 a) 2

b) 0.25 L/ha

c) None

3 NL

Cauliflower Broccoli Head Cabbage Brussels sprout

F Lepidoptera Pieris spp. Mamestra brassica Evergestis forficalis Clepsis spectrana Plutella xylostella


BBCH 12-49

(Mar-Nov)

2 (7 days)

0.5 L/ha 50 g/ha 300-800

7 a) 2

b) 1 L/ha

c) None

4 Whitefly Aleyrodes proletella

0.75 L/ha

75 g/ha a) 2

b) 1.5 L/ha

c) For improved performance on whitefly use with the addition of a suitable oil adjuvant

5 NL Carrots, parsnips, celeriac, hamburg root parsley (turnip-rooted parsley), skirret

F Diptera Chamaepsila rosae


BBCH 11-89

(Mar-Nov)

2 (10 days) 0.75 L/ha

75 g/ha 300-1000 14 a) 2

b) 1.5 L/ha

c) None

6 NL Bulb vegetables (Onion, Shallots, Garlic) and Stem vegetables (Leek,

F Thrips Thrips tabaci Frankliniella occidentalis


BBCH 12-80

(April-Oct)

2 (7 days) 0.75 L/ha

75 g/ha 200-800 14 a) 2

b) 1.5 L/ha

c) For improved performance on sucking pests use with

Benevia Part A

National addendumt – Field - The Netherlands

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spring onion) the addition of a suitable oil adjuvant.

Minor uses according to article 51

7 NL Swede, red beet, celeriac, black salsify

F Lepidoptera Mamestra brassica Pieris spp.


BBCH 11-89

(Mar-Nov)

2 (10 days) 0.5 L/ha 50 g/ha 300-1000 14 a) 2

b) 1.0 L/ha

c) None

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3 RISK MANAGEMENT

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform

Principles

3.1.1 Physical and chemical properties (Part B, Section 1, Points IIIA 2.0 and IIIA 4.0)

Benevia was one of the representative products in the DAR (then named Cyantraniliprole 100 g/L OD).

Consequently, the majority of the data summarised has been reproduced from the DAR, where they were

evaluated during the EU review.

Safety: Benevia is non-flammable, non-explosive, and not an oxidizer. The auto-ignition temperature was

determined to be 254°C, and therefore considered to be not self-igniting. The pH of a 1% concentration of the

preparation in water was between 4.9-5.1 pH units. The kinematic viscosity at 40°C is not provided, however

the content H304 classified components is <10%. The surface tension indicates that the formulation is surface

active and the relative density is 0.978 at 20°C.

Performance: Benevia has an off white colour with a mild oily characteristic odour.. The physical and chemical

properties of the preparation were measured using CIPAC Methods, when available. All physical and chemical

properties specifications, as defined by “The 3Manual on the Development and Use of FAO/WHO

Specifications for Plant Protection Products,” were met both prior to and after completion of high, ambient and

low temperature storage. The preparation was stored at a temperature of 54°C for a period of 2 weeks and at 0°C

for a period of one week and 3 years at ambient temperature in PET and coex-HDPE/EVOH, as required by the

relevant test methods. Based on the results of the accelerated storage test, a low temperature storage test, and a

three-year shelf-life storage stability at ambient temperature test it can reasonably be assumed that Benevia will

be stable under expected storage conditions in the Netherlands for 2 years in coex-HDPE/EVOH packaging.

The technical properties are acceptabl for an OD-formulation.

Implications for labelling: None

Compliance with FAO specifications: The product complies with FAO specifications.

Tank mixtures: Cyantraniliprole was tested with various potential tank mix partners in two-way combinations.

Method(s) and results are presented in the Benevia Registration Report, Part B, Section 7, DuPont-35950 CEU.

Tank mixes could therefore be mentioned on the product label for Benevia, however no specific tank mix

recommendations are included in the product label.

Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of

opening, type of closure, strength, leak proofness, resistance to normal transport and handling, resistance to and

compatibility with the contents of the packaging, have been submitted, evaluated, and is considered to be

acceptable.

Nature and characteristics of the protective clothing and equipment: Boots, gloves and coveralls are

required during preparation of the spray liquid.

3.1.2 Methods of analysis (Part B, Section 2, Point IIIA 5.0)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point IIIA 5.2)

Benevia was a representative formulation in the EU review of cyantraniliprole. Analytical methods for

determination of cyantraniliprole in Benevia were evaluated as part of the EU review of Benevia. All data are

considered adequately validated according to SANCO/3030/99 rev. 4.

The impurities IN-Q6S09, IN-RYA13, methanesulfonic acid, acetonitrile, heptane and 3-picoline were

considered relevant in the technical material (EFSA Conclusion (EFSA Journal 2014, 12 (9):3814)). Analytical

methods for these relevant impurities except methanesulfonic acid are considered adequately validated

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according to SANCO/3030/99 rev. 4. For impurity methanesulfonic acid attempts were made to develop a

method for methanesulfonic acid employing a common technique: ion chromatography with detection by

conductivity. However, numerous interferences from formulation ingredients were detected, which precluded

the accurate quantitation of methanesulfonic acid. An alternative approach employing ion chromatography with

detection by mass spectrometry has been developed and has been provided. This study has not been evaluated

by the zRMS and is therefore summarized below (KIIIA1 5.2.4/04).

There are no existing CIPAC methods for cyantraniliprole in OD-formulations.

Report: KIIIA1 5.2.4/04, Robson, D. 2017

Title: DESCRIPTION AND VALIDATION OF THE ANALYTICAL METHODS FOR

DETERMINATION OF METHANESULFONIC ACID IN CYANTRANILIPROLE (DPX-

HGW86) END-USE PRODUCTS

This study was conducted to provide analytical data for the validation of the analytical method

for determination of methanesulfonic acid in cyantraniliprole (DPX-HGW86) end-use

products. This includes data for specificity, linearity, limits of detection/quantitation, accuracy,

precision, and confirmation of identity.

Document No: DuPont-46998

Guidelines: Guidance document SANCO/3030/99 rev.

GLP Yes (certified laboratory)

Principle of the method Methanesulfonic acis is ultrasonically extracted from a weighed sample of 100 OD

cyantraniliprole (DPX-HGW86) and analyzed by ion chromatography (IC) using

mass spectrometry detection (m/z/ 95.1) with an IonPac AS 19 column. External

standard technique is used for method calibration. The applicable concentration

range for methanesulfonic acid is 0.0001-0.009 mg/mL (0.001-0.09% for a 2

mg/mL (100 OD) sample solution concentration).

Precision data

methanesulfonic acid Injection

number

Concentration

(mg/mL)

Average

peak

area

Weight

(%)

Average

weight

(%)

RSD

(Modified

Horwitz)

(%)

1 1.99 1979.3 0.00733

0.00700 5.07

(5.66)

2 1.86 1837.9 0.00708

3 2.09 1990.1 0.00703

4 2.37 2172.2 0.00695

5 2.47 2115.9 0.00646

6 2.13 1911.8 0.00652

7 2.51 2386.0 0.00742

8 2.35 2225.7 0.00724

Accuracy data methane

sulfonic acid Spike (batch

DPX-

HGW86)

Sample

prep

(mg/mL)

Spiked in

technical

(mg/mL)

Native in

sample

(mg/mL)

Average

(n=2)

(mg/mL)

Recovery

(%)

(between

75-120%)

Low 1 (750) 2.45 0.0016023 0.000804 0.0024225 101.04

Low 2 (750) 2.79 0.0016023 0.000915 0.0024455 95.51

High 1 (750) 2.86 0.0128180 0.000938 0.0136195 98.94

High 2 (750) 2.425 0.0128180 0.000795 0.0134977 99.10

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Low 1 (797) 10.125 0.0016023 0.001418 0.0028883 91.80

Low 2 (797) 9.635 0.0016023 0.001349 0.0028218 91.93

High 1 (797) 9.805 0.0128180 0.001379 0.0136821 96.03

High 2 (797) 9.920 0.0128180 0.001389 0.0136031 95.29

Low 1 (802) 2.63 0.0002272 0.000299 0.0004936 85.50

Low 2 (802) 2.31 0.0002272 0.000263 0.0004873 98.75

High 1 (802) 2.44 0.0045445 0.000278 0.0040930 83.96

High 2 (802) 2.305 0.0045445 0.000262 0.0040160 82.60

Low 1 (812) 1.895 0.0002272 0.000133 0.0003996 117.50

Low 2 (812) 2.2 0.0002272 0.000154 0.0003950 106.05

High 1 (812) 1.95 0.0045445 0.000137 0.0041630 88.60

High 2 (812) 2.48 0.0045445 0.000174 0.0044023 93.05

Linearity 8 levels in duplicate between 0.000114 and 0.009089 mg/mL in standards in

solvent (corresponding to 0.0006 – 0.05%).

Y95.1=1.0e+007X+524.03 (r=0.9988)

Specificity The specificity was established by demonstrating the purity of the IC peaks of

interest versus potential interferences. Solutions of each component were prepared

using standard materials, and injected in duplicate. Chromatograms were examined

to determine if there was complete separation between known impurity and

formulation peaks and the Methanesulfonic Acid peak being measured by the

method. No interferences were found in the end use product material. The

methanesulfonic acid exists in the formulation ingredients thus it is also present in

the formulation blank.

Confirmation:

Confirmation of impurity identities is accomplished utilizing two techniques: First,

the chromatographic peak retention time, generated from Manufacturer-

characterized analytical standard, is compared to the peak retention time for

methanesulfonic acid in DPX-HGW86 end-use products. Second, IC/MS spectral

data are generated for the impurity analytical standard chromatographic peaks. The

spectra are compared with the associated chromatographic peaks for a sample

solution. For non-detectable impurity components in the sample solution, a fortified

sample solution is analyzed.

A solution of methanesulfonic acid and DPX-HGW86 formulated material were

prepared as specified in the Analytical Method section of this report. IC/MS

spectral data for methanesulfonic acid in DPX-HGW86 were generated utilizing a

Dionex 2000 ICS with a Dionex MSQ and Chromeleon software. Typical

chromatograms are provided in the report.

Limit of Quantification

and Limit of detection Component

Actual

amount

(mg/mL)

Amount

found

(mg/mL)

Recovery

(%)

RSD (n=7)

(Modified

Horwitz)

(%)

Methanesulfonic

acid (100 OD

formulation

concentration is

2 mg/mL)

0.000114

(equivalent

to 0.0006%

w/w in 100

OD

formulation)

0.000126 110.82

5.61

(10.26)

0.000133 116.87

0.000124 117.67

0.000147 129.26

0.000138 121.07

0.000134 117.42

0.000125 109.45

A solution of methanesulfonic acid was prepared at the concentration equivalent to

the targeted limit of quantitation. A minimum of six injections are made. The mean

recovery, standard deviation and relative standard deviation (RSD) are calculated.

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The RSD is compared to the Horwitz limit for acceptability. The limit of detection

is calculated from the limit of quantitation. The LOQ is established at 0.0006 %

w/w and the LOD is calculated at 0.002% w/w.

Matrix-effect Not provided.

Extract and standard

stability

The standard and sample solutions are stable for 48 hours.

Conclusion RMS The analytical method is fully validated in terms of specificity, linearity, accuracy

and repeatability for the determination of the relevant impurity methanesulfonic

acid in the formulation Benevia with an LOQ of 0.0006%.

3.1.2.2 Analytical method for residues (Part B, Section 2, Points IIIA 5.3 to IIIA 5.8)

All analytical monitorings/enforcement methods for plant and animal matrices and the environmental matrices

soil, water and air have been developed and are active substance data and were provided in the EU review of

cyantraniliprole and were considered adequate.

The analytical method for the determination of cyantraniliprole residues in surface water is compliant with

Dutch national requirements (LOQ ≤ 0.1 µg/L for cyantraniliprole).

3.1.3 Mammalian Toxicology (Part B, Section 3, Point IIIA 7.0)

3.1.3.1 Acute Toxicity (Part B, Section 3, Point IIIA 7.1)

Benevia was a representative formulation in the EU review of cyantraniliprole. The acute toxicity studies for

Benevia were evaluated during the review and were considered adequate.

Benevia has low acute toxicity and is not irritating to eyes or skin. Benevia may cause allergic skin reactions.

Benevia is classified as a skin sensitiser (GHS07) with the hazard statement H317.

3.1.3.2 Operator Exposure (Part B, Section 3, Point IIIA 7.3)

Benevia was a representative formulation in the EU review of cyantraniliprole. The intended use pattern is

within the use pattern considered for EU review. Operator risk assessments of Benevia for all uses show no

operator risk without PPE and default values using the German and UK POEM models.

3.1.3.3 Bystander and Resident Exposure (Part B, Section 3, Point IIIA 7.4)

In the original evaluation, the risk assessment for bystanders and residents was performed with the UK model.

For the Netherlands, a calculation with the DE model is also required. Based on the risk assessment using both

the UK model and the DE model, it is concluded that there is no undue risk to any bystander or resident after

accidental short-term exposure to Benevia.

3.1.3.4 Worker Exposure (Part B, Section 3, Point IIIA 7.5)

Worker exposure to cyantraniliprole resulting from contact from foliage treated with Benevia during hand

harvesting activities has been calculated using the EUROPOEM II re-entry model. The systemic exposure to

individuals undertaking hand harvesting activities is estimated to be equivalent to 3% of the systemic AOEL for

cyantraniliprole. This value is within acceptable limits and no further assessment is required.

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3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point IIIA 8.0)

3.1.4.1 Residues (Part B, Section 4, Points IIIA 8.3 and 8.7)

Benevia is an OD formulation containing 100 g/L cyantraniliprole for use as an insecticide on a wide variety of

arable and vegetable field crops. Plant and animal metabolism data for cyantraniliprole was submitted and

evaluated in the EU DAR.

The intended use of the product within this application is on potato, cauliflower, broccoli, head cabbage,

Brussels sprout, carrots, parsnips, celeriac, hamburg root parsley (turnip-rooted parsley), skirret and swede, red

beet, celeriac, black salsify.

The proposed use of cyantraniliprole on potato is within the uses considered in the cyantraniliprole DAR. For

the other uses, new residues trials data has been submitted and evaluated in Part B section 4 (zRMS UK). The

trials are sufficient to support the proposed GAPs in each case. Results of the residue trials showed that the

current EU MRLs for the crops under consideration will not be exceeded if the product is used according to the

intended GAPs with the exception of leek where an MRL of 0.8 mg/kg is calculated on the basis of the data

(0.011, 0.012, 0.061, 0.09, 0.11, 0.24, 0.32, 0.38 mg/kg). The current MRL for cyantraniliprole in leek is 0.01*

mg/kg. The use on leek cannot be supported unless the MRL is raised.

Rotational crops data has been considered previously in the EU DAR. The rotational crop trials considered in

the cyantraniliprole DAR indicated that residues of cyantraniliprole above the LOQ are not expected in

rotational crops at a single seasonal application rate (1 x 450 ai/ha to soil before planting of wheat, beetroot and

lettuce). However, the DT90 in soil were estimated to be in the range of 4 to 9 years for several metabolites.

Accordingly, since accumulation of several very persistent metabolites is expected following multiple years of

consecutive applications, EFSA is of the opinion that the submitted trials conducted with a single seasonal

application rate are not fully appropriate to address the transfer of cyantraniliprole residues in rotational crops.

Additional data was required to address the possible transfer of persistent soil metabolites in rotational crops.

following multiple years of consecutive applications (EFSA Journal 2014; 12(9):3814).

In the DAR for cyantraniliprole, accumulated PECsoil values were calculated for four critical GAPs and the

confined and field rotational crop studies. The accumulated PECsoil values indicate that metabolites would be

present in the soil at the time of planting at levels >0.01 mg/kg. However, based on the results of the rotational

crop metabolism study, it appears that these metabolites are not taken up by the plant, as very low levels of

metabolites (<0.005 mg/kg) were observed even at the first plant back interval. Levels of metabolites in food

commodities decreased further at the longer plant back intervals. A similar trend was observed in feed

commodities (wheat straw, hay and forage) (<0.08 mg/kg in crops planted after 365 days). In agreement with

the analysis of zRMS UK, accumulated PECsoil levels which correspond to the proposed GAP, are lower than

the PECsoil for the metabolites expected after the confined rotational crop study. Accumulated PECsoil levels

which correspond to the proposed GAP (and take into account seven annual treatments at that GAP leading to a

plateau level), are at most two thirds of the PECsoil for the metabolites expected after the confined rotational

crop study. Therefore it is considered that residues in food and feed commodities will be lower in commodities

treated at the GAP. On the basis of this outcome in order to mitigate the risk of metabolites with undetermined

toxicological relevance being present in food commodities, the zRMS proposed restricting application in

accordance with the GAP to a maximum of once per year and to state that no other cyantraniliprole containing

products must be applied in the same year. Therefore the following restriction is included on the WG: “Om

residuen in voedings- of voedergewassen ten gevolge van ophoping van persistente bodemmetabolieten te

voorkomen, is het gebruik van dit product beperkt tot 2 toepassingen per jaar volgens het gebruiksvoorschrift.

Dit product, of andere producten die cyantraniliprole bevatten, mogen gedurende hetzelfde jaar niet nogmaals

op hetzelfde perceel worden toegepast.”

Sufficient processing data was available in the EU DAR to support the proposed uses except for the pickling of

cabbage. New data was submitted to support this processing procedure. As there is different residue definition

for processed plant commodities and the RAC is in place, the residue levels in the processed commodities were

considered in the risk assessment. The worst case STMR (accounting for the highest conversion factor and

processing factor and assuming that all of the commodity is consumed) lead to an estimate which did not exceed

the ADI, and hence further consideration of consumption patterns was not required.

Consideration of livestock intakes from produce treated at the proposed GAP indicates that no further

consideration of likely residues in animal commodities is required.

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3.1.4.2 Consumer exposure (Part B, Section 4, Point IIIA 8.10)

Chronic intakes for all consumer groups are below the ADI of 0.01 mg/kg for cyantraniliprole therefore no

health effects are expected. With the current EFSA model the chronic risk assessment ranges from 11.0 to

70.1% of ADI. The diet with the highest TMDI is “WHO Cluster Diet B”. For this diet, the highest contributor

is tomatoes with 13.0% of ADI. The second diet with the highest TMDI is “NL Child” with 69.5% of ADI

where spinach is the major contributor with 17.9% of ADI. An assessment of acute dietary intake (NESTI) has

not been made as cyantraniliprole is not acutely toxic and an ARfD has not been allocated.

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point IIIA 9.0)

Predicted environmental concentrations in soil are revised according to the EFSA Conclusion.

3.1.5.1 Predicted environmental concentration in soil (PECsoil) (Part B, Section 5, Points IIIA 9.4

and IIIA 9.5)

Predicted environmental concentrations in soil (PECsoil) for cyantraniliprole, its soil metabolites IN-JCZ38,

IN-JSE76, IN-K5A79, IN-PLT97, IN-J9Z38, IN-K5A77, IN-K5A78, and IN-M2G98 and photo-degradation

products IN-QKV54 and IN-RNU71 were assessed following the long-term application of Benevia formulation

in the field, assuming that the product is used at the maximum single use rate of 200 g a.s./ha (i.e., 2 × 100

g a.s./ha), with 0% foliar interception. The application rate of 2 × 100 g a.s./ha is protective of use of Benevia

formulation on all the crops. The Benevia formulation is intended for use in potatoes, strawberry, cauliflower,

broccoli, head cabbage, Brussels sprouts, carrot, wild parsnip, celeriac, turnip-rooted parsley, head and

flowering brassica, bulb vegetables (onions, shallots, garlic), stem vegetables (leek, spring onion) and root and

tuber vegetables.

Input parameters recommended in the EFSA conclusion (EFSA, 2014) were used in PECsoil calculation for both

cyantraniliprole and metabolites. The maximum plateau and time-weighted average (TWA) concentrations of

PECsoil were calculated using the method based on the recommendations of FOCUS (1996) and on the Guidance

Document on Persistence of Soil (EU Commission, 2000) and recommended in the revised Cyantraniliprole

Draft Assessment Report Volume 3, B8, June 2014.

The PECsoil of cyantraniliprole after multiple years of application was calculated by summing up contributions

of previous years of application at time t. The maximum PECsoil over a period of 20 years was selected as a

plateau concentration. The actual and time weighted average PECsoil after the peak concentration was calculated

and reported in support of ecotoxicological assessment. The same method was also used to calculate the actual

and time weighted average PECsoil for metabolites. However, the application rate of metabolites is calculated by

multiplying the parent application rate by the maximum percentage of metabolite observed in soil degradation

study, the molecular weight ratio of metabolite to parent, and then the ratio of plateau PECsoil to initial PECsoil of

cyantraniliprole (revised Cyantraniliprole Draft Assessment Report Volume 3, B8, June 2014).

The overall maximum PECsoil of cyantraniliprole after application with Benevia formulation is predicted to be

0.299 mg a.s./kg soil. The maximum PECsoil values for IN-JCZ38, IN-JSE76, IN-J9Z38, IN-K5A77, IN-K5A78,

IN-K5A79, IN-M2G98, IN-PLT97, IN-QKV54, and IN-RNU71 from either calculation method are 0.143,

0.273, 0.619, 0.062, 0.377, 0.033, 0.009, 0.253, 0.134, and 0.091 mg/kg soil, respectively.

The results indicate that neither cyantraniliprole nor its metabolites will accumulate in soils after the long-term

application on target crops.

The results for PECsoil for the active substance and its metabolites were used for the ecotoxicological risk

assessment.

3.1.5.2 Predicted environmental concentration in ground water (PECgw) (Part B, Section 5,

Point IIIA 9.6)

The leaching behaviour of cyantraniliprole and its metabolites IN-JCZ38, IN-J9Z38, IN-JSE76, IN-K5A77,

IN-K5A78, IN-K5A79, IN-PLT97, IN-M2G98, IN-RNU71, IN-NXX70, and IN-QKV54 was assessed multiple

application dates to cover the uses at a wide range of BBCH stages such as BBCH 12-89. Therefore, the

simulations for cyantraniliprole and its soil metabolites were conducted with the Tier 1 endpoints from the

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EFSA conclusion (EFSA, 2014a). In addition, simulations were also conducted with the degradation endpoints

of metabolites as derived from pathway kinetic analyses for ten field dissipation studies. For photo-degradation

products, the simulations under different application dates were conducted using the Tier 2 modeling endpoints

only, which was agreed by Ctgb (2017).

The leaching behaviour assessment was carried out in compliance with the Dutch decision tree for the

evaluation of pesticide leaching (Cornelese and Pol, 2010; van der Linden et al., 2004). Thus, the ground water

simulations were conducted following a tiered approach using the leaching model GeoPEARL 3.3.3, in

compliance with the Dutch decision tree for the evaluation of pesticide leaching. A plant uptake factor of 0.5 for

cyantraniliprole and 0.0 for metabolites was used in the simulation. A Q10 of 2.58 was used. The foliar

interception rate from the FOCUS guidance (FOCUS, 2011) was applied based on the BBCH stages of crops but

they are either the same as or even more conservative than those recommended in the EFSA guidance (2014b).

Since lettuce, cauliflower, broccoli, head cabbage, and Brussels sprout crops are not available in the GeoPEARL

crop groups, cabbage is used as a representative surrogate crop in the modeling. Similarly, onion is used as

surrogate representative crop for bulb vegetables, shallots, garlic, and leeks, and the sugar beet is used as

surrogate representative crop for carrots, root and tuber vegetables.

Tier 1 and Tier 2 PECgw of cyantraniliprole and its soil metabolites:

At Tier 1, the modeling endpoints recommended in the revised Draft Assessment Report for cyantraniliprole

(UK CRD, 2014) and accepted in the EFSA conclusion (EFSA, 2014a) were used. The degradation of

cyantraniliprole in soils under laboratory conditions displays a significant pH dependency (r2 = 0.99), with a

regression equation of DT50 = -21.174 pH + 185.83. Therefore, “calculated” half-life option was selected in

GeoPEARL to use the regression equation. The longest DegT50 of 87.0 days measured at pH 4.6 and shortest

DegT50 of 13.3 days for cyantraniliprole measured at pH 7.9 was used as maximum and minimum limit in the

model. In addition, the arithmetic mean KFOC of 26 L/kg for IN-K5A79 in soils of pH > 6.5 was also used due

to pH dependency of adsorption.

At Tier 2, for the parent compound, as recommended in the revised DAR (UK CRD, 2014), the laboratory

degradation DT50 and FOCUS field DT50 (calculated from field dissipation studies following the FOCUS

guidance (2006)) were pooled together and examined for its pH dependency. As pH dependency is significant,

the geomean DT50 of 52.2 days for the combined lab and field DT50 at pH < 7.0 was used to assess leaching

risk of cyantraniliprole. The PECgw of metabolites with the Tier 2 field endpoints under multiple application

dates are not calculated.

Tier 2 PECgw of photo-degradation products

The photodegradation products of cyantraniliprole were also simulated using a tiered approach, as requested by

RMS - UK CRD (UK CRD, 2014) in the original report – DuPont-37848 NL., Tier 1 and Tier 2 modeling

endpoints of photo-degradation endpoints are accepted for modeling. Thus, only the Tier 2 simulation was

conducted at the early, middle, and late application dates.

The Tier 2 simulation was conducted with the formation fractions (0.05 for both transformation routes) based

on the upper limit of total photodegradation products observed in the field dissipation studies.

Tier 1 and Tier 2 simulation using EFSA approved endpoint at early, middle, and late application dates

At Tier 1, the 90th percentile PECgw of cyantraniliprole was below 0.01 μg/L for cabbage, onion, and potatoes

at all the application dates. For strawberries at early, middle, and late application dates and for carrots at early

application date, the 90th percentile PECgw of cyantraniliprole is above 0.01 μg/L but below 0.1 μg/L (Table 1).

The 90th percentile PECgw of metabolites IN-JCZ38, IN-J9Z38, and IN-K5A77 was predicted to be <0.001

μg/L for all crops at all application dates.

The 90th percentile PECgw of metabolites IN-K5A78 and IN-PLT97 is < 0.1 μg/L for potatoes at all application

dates, but > 0.1 μg/L and < 0.75 μg/L for all other crops at all application dates or at least one application date

(carrots).

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The 90th percentile PECgw of the metabolites IN-JSE76 and IN-K5A79, and IN-M2G98 are > 0.75 μg/L for

some crops at certain application dates but <10 μg/L for all crops at all application dates.

At Tier 2, the 90th percentile PECgw of cyantraniliprole as predicted with DegT50 of 52.2 days for

cyantraniliprole was below 0.01 μg/L for carrots, strawberries, and potato, while, it slightly exceeded 0.01 μg/L

for onion at the early, middle, and late application dates and cabbage at the early application date.

Since the degradation of cyantraniliprole is pH dependent, it is recommended that the Tier 1 PECgw to be used

in leaching risk assessment.

Tier 2 simulation for photo degradation products

The Tier 2 90th percentile PECgw of photodegradation products of cyantraniliprole and its metabolites were

predicted to be less than 0.01 μg/L for all crops at all application dates, except for the metabolite IN-RNU71.

For IN-RNU71, the 90th percentile PECgw of metabolite IN-RNU71 are < 0.01 μg/L for potatoes at all

application dates, and > 0.01 μg/L but < 0.1 μg/L for all other crops.

Metabolites IN-JSE76 and IN-PLT97 have been proven to not be toxicologically relevant. For metabolite IN-

K5A79 a non-relevance package has been submitted accepted. Metabolite K5A79 is therefore judged to be not

toxicologically relevant.

Refined modelling for metabolite IN-M2G98

A refined PECgw modelling for metabolite IN-M2G98 was provided. The results clearly indicated that IN-

M2G98 is not likely to pose leaching risk to ground water in the Netherlands, given the restriction for use in

drinking water protection areas stated below.

In conclusion, the results with multiple application dates in this study indicate that the OD formulation of

cyantraniliprole does not pose ground water leaching risk if the product is applied in the Netherlands according

to the label instructions. However, for all uses with the exception of potatoes it should be indicated on the label

of the product that application in groundwater protection areas is prohibited (as stated in the Netherlands CTGB

Evaluation Manual) due to the metabolite IN-RNU71.

This results in the following restriction sentence placed on the WG: “Om het grondwater te beschermen mag dit

product in de teelt van sluitkoolachtigen, bloemkoolachtigen, wortelgewassen, knolselderij, ui-achtigen, prei,

koolraap, rode biet, knolselderij en schorseneer niet worden gebruikt in grondwater beschermingsgebieden.”

3.1.5.3 Predicted environmental concentration in surface water (PECsw) (Part B, Section 5,

Points IIIA 9.7 and IIIA 9.8)

Predicted environmental concentrations in surface water (PECsw) and sediment (PECsed) were calculated for

cyantraniliprole and its major water and sediment metabolites in order to support Benevia authorization in the

Netherlands. All major aquatic metabolites (IN-J9Z38, IN-K5A77) and the photo-degradation metabolites (IN

QKV54, IN-RNU71 and IN-NXX70) of cyantraniliprole were included in the assessment using the endpoints

recommended in the revised Cyantraniliprole DAR Volume 3, B8, June 2014 and in the EFSA conclusion on

cyantraniliprole (EFSA, 2014Fout! Bladwijzer niet gedefinieerd.).

The PECsw PECsed calculations for the Dutch standard edge-of-field ditch were carried out using the assessment

tool TOXSWA v.1.2 (Beltman and Adriaanse, 19991) following guidance from the Ctgb Evaluation Manual

(Ctgb, 2014Fout! Bladwijzer niet gedefinieerd.). The assessment of surface water destined for drinking water production

was performed according to the NL guidance (Ctgb, 2014Fout! Bladwijzer niet gedefinieerd.). The PECTier1 at the

abstraction points and polder Bommelerwaard were calculated by the DROPLET model v. 1.1 (Van Leerdam et

1 Beltman, W. H. J. and Adriaanse, P. I. (1999): User's manual TOXSWA 1.2; simulation of pesticide fate in small surface waters. Technical

Document 54. DLO Winand Staring Centre Wageningen, The Netherlands.

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al., 20102). The calculations were performed for the Ctgb standard spring and autumn scenarios considering

standard drift rates of 1 % for vegetables (bulb, leafy, and root) and potatoes.

The overall maximum predicted environmental concentrations of cyantraniliprole in surface water calculated for

the use in vegetables (bulb and leafy) considering drift rates of 1% were calculated to be 0.682 µg/L for the

spring applications in the edge-of-field ditch. Highest PECsed for cyantraniliprole was 0.0176 mg/kg.


the use in vegetables (root) considering drift rates of 1% were calculated to be 0.675 µg/L for the spring

applications in the edge-of-field ditch. Highest PECsed for cyantraniliprole was 0.0175 mg/kg.


the use in potatoes considering drift rates of 1% were calculated to be 0.113 µg/L for the spring applications in

the edge-of-field ditch. Highest PECsed for cyantraniliprole was 0.003 mg/kg.

The overall maximum predicted environmental concentrations of the metabolites IN-J9Z38, IN-K5A77,

IN-RNU71, IN-NXX70, and IN QKV54 in surface water calculated for the use in vegetables (bulb and leafy)

considering drift rates of 1% were calculated to 0.492, 0.074, 0.095, 0.276, and 0.343 µg/L, respectively. The

maximum concentrations in sediment were 0.116, 0.018, 0.002, 0.062, and 0.078 mg/kg.

The overall maximum predicted environmental concentrations of for the metabolites IN-J9Z38, IN-K5A77,

IN-RNU71, IN-NXX70, and IN QKV54 in surface water calculated for the use in vegetables (root) considering

drift rates of 1% were calculated to be 0.478, 0.072, 0.094, 0.267, and 0.331 µg/L, respectively. The maximum

concentrations in sediment were 0.114, 0.018, 0.002, 0.061, and 0.077 mg/kg.

The overall maximum predicted environmental concentrations of the metabolites IN-J9Z38, IN-K5A77,

IN-RNU71, IN-NXX70, and IN QKV54 in surface water calculated for the use in potatoes considering drift

rates of 1% were calculated to be 0.081, 0.012, 0.016, 0.046, and 0.055 µg/L, respectively. The maximum

concentrations in sediment were 0.020, 0.003, <0.001, 0.011, and 0.014 mg/kg.

Results for the Dutch drinking water abstraction points (PECTier1) calculated using a default market share

parameter of 0.4 at all nine drinking water abstraction points and the Bommelerwaard polder were calculated to

be <0.001 µg/L, thus well below the drinking water standard (0.1 µg/L).

It can be concluded that the use of cyantraniliprole is not likely to pose an unacceptable risk to drinking water

from surface water in the Netherlands if the active substance is used in compliance with label recommendations.

The calculated PECsw, PECsw twa, and PECsed values are considered suitable to be used in the subsequent

ecotoxicological risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PECair) (Part B, Section 5, Point

IIIA 9.9)

Volatilisation of cyantraniliprole is negligible as indicated by a vapour pressure of 5.133 × 10-15 Pa at 20°C. It

can be estimated that <0.0001% (5.55 × 10-14 percent) of applied cyantraniliprole would be lost from a treated

field into the air within 24 hours. This rate of loss is likely to result in negligible concentrations in air (PECair)

due to the combination of a low rate of loss as well as the dilution effects of moving air.

2 Van Leerdam, R.C., Adriaanse, P.I., ter Horst, M.M.S. and te Roller, J.A. (2010): DROPLET to calculate concentrations at drinking water

abstraction points – User manual for evaluation of agricultural use of plant protection products for drinking water production from

surface waters in the Netherlands. Alterra-report 2020, Wageningen.

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3.1.6 Ecotoxicology (Part B, Section 6, Point IIIA 10.0)

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points IIIA 10.1 and IIIA 10.3)

Birds

Benevia was a representative formulation in the EU review of cyantraniliprole. The avian risk assessment was

conducted according to the ‘Guidance of EFSA. Risk Assessment for Birds and Mammals’, European Food

Safety Authority (EFSA), Parma, Italy. EFSA Journal 2009: 7(12):1438.

The acute, short-term, and long-term risks of Benevia to birds were assessed from toxicity exposure ratios

between toxicity endpoints, estimated from studies with cyantraniliprole, and maximum residues occurring on

food items and drinking water following applications according to the proposed use pattern.

The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute and

short-term risk and 5 for long-term risk (including drinking water and secondary poisoning), thus indicating no

unacceptable risk to birds from the proposed uses.

Terrestrial vertebrates (other than birds)

Benevia was a representative formulation in the EU review of cyantraniliprole. The mammal risk assessment

was conducted according to the ‘Guidance of EFSA. Risk Assessment for Birds and Mammals’, European Food

Safety Authority (EFSA), Parma, Italy (EFSA Journal 2009: 7(12):1438). The TERa and TERlt values for

Benevia are higher than the Annex VI trigger values, indicating that Benevia poses no unacceptable risk to

mammals following application of Benevia at the proposed use rates.

The long-term hazard quotient (HQ) for exposure via drinking water is below the trigger value of 50 for less

sorptive substances (Koc <500 L/kg) indicating a low risk to mammals via the uptake of drinking water in

puddles and that no specific calculations of exposure and TERlt are necessary.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point IIIA 10.2)

Following acute toxicity exposure ratios (TERa) and chronic toxicity exposure ratios (TERlt) on fish for

cyantraniliprole using the Dutch Model, the TERa and TERlt values for cyantraniliprole based on the worst-case

PECsw exceed the Regulation (EC) 546/2011 trigger of 100 for acute exposure. Therefore Benevia, when used

according to Good Agricultural Practices, will pose a low risk to fish in the Netherlands.

Following acute toxicity exposure ratios (TERa) and chronic toxicity exposure ratios (TERlt) on Daphnia

magna for cyantraniliprole and its metabolites based on worst-case PECsw, the TERa and TERlt value for

cyantraniliprole is lower than the Regulation (EC) 546/2011 trigger of 100, indicating a potential acute risk and

low long-term risk to aquatic invertebrates. The acute TER values for the metabolites of cyantraniliprole are

greater than the Regulation (EC) 546/2011 trigger of 100, indicating a low acute risk to aquatic invertebrates.

To evaluate inter-species variability in detail, the effect endpoints on the active substance cyantraniliprole were

re-evaluated to construct a species sensitivity distribution from which an HC5 was obtained. The agreed

assessment factor (AF) remains 3. An additional safety factor of 2.2 was applied to account for the difference in

toxicity between formulation and active substance.

Toxicity exposure ratios were calculated using the refined HC5 and worst-case PECsw value. The acute TER

based on the HC5 for aquatic invertebrates exceeds the trigger of concern, indicating low acute to aquatic

invertebrates risk following application of Benevia according to the proposed use pattern.

Because the TERa values for Daphnia magna indicated that cyantraniliprole poses low acute risk to aquatic

invertebrates, an acute risk assessment to aquatic insects is not needed since Daphnia magna was identified as

the most sensitive aquatic invertebrate, including aquatic insects, when exposed to cyantraniliprole in acute

toxicity tests.

Acceptable chronic risk to aquatic invertebrates could not be demonstrated. Drift reduction of 75% is required to

achieve acceptable chronic risk to aquatic invertebrates. Additional restriction sentence for aquatic organisms

however is not required because drift mitigation measures for non-target arthropods are more strict and are

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sufficient to ensure acceptable risk to aquatic organisms. Restriction sentence for non-target arthropods was

adapted also to account for aquatic organisms.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points IIIA 10.4 and

IIIA 10.5)

Bees

The attractiveness of the crop plant to honeybees may be considered as an entry point for this risk assessment.

The intended use in potato is BBCH 12-70, in cauliflower, broccoli, head cabbage, brussels sprout is BBCH 12-

49, in carrots, parsnips, celeriac, turnip-rooted parsley is BBCH 11-89, and in swede, red beet, celeriac, black

salsify is BBCH 11-89. Of all these, according to CTGB guidance potatoes is to be considered a bee-attractive

crop. As the flowering period is at BBCH 60-69 and this falls within the BBCH ranges applied for, bees could

be directly exposed to the product if treatment of these crops occurs during flowering.

The risk assessment for bees is based on the Hazard Quotient (HQ), see 10.4.1., the ratio between the highest

single application rate and toxicity endpoint (LD50 value). Where there is a possibility of honeybees being

exposed, no authorization shall be granted if the hazard quotients for oral or contact exposure of honeybees are

greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions

there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development

after use of the plant protection product according to the proposed conditions of use.

For use in potatoes the hazard quotients are below the trigger of 50 (see Fout! Verwijzingsbron niet

gevonden.). ‘Benevia’ in potato crops (2 x 12.5 g a.s./ha with a 7-day minimum spray interval) poses a low risk

to bees. Therefore, product authorisation is agreed for this use without need for bee related risk mitigation

measures.

For use in leafy, bulb, root and fruiting vegetables the in-field QHC and QHO are above the trigger of 50,

indicating a possible risk for honey bees when used in bee-attractive crops (which these crops are not) or when

bees are foraging in the field for another reason (flowering weeds or honeydew). Based on the default national

drift value an off-field risk to honeybees could be excluded for all leafy, bulb, root, fruiting vegetables. Further

work including semi-field and tunnel studies was conducted to assess the potential in-field risk to bees under

actual conditions of use. These studies were considered previously in the revised DAR, Vol.3 B.9. Part B (2014)

and the results are briefly summarised in the EFSA (2014) peer review conclusion. The results of these tests are

that it is unlikely that Benevia sprayed twice at up to 75 g cyantraniliprole/ha with one spray made during

flowering and after daily honeybee foraging activity poses a risk to honeybees. Flowering weeds growing in

fields might also attract bees and be sprayed.

Acceptable in-field risk to bees could not be achieved for all uses except potatoes. Acceptable off-field risk was

demonstrated for all uses. To achieve acceptable risk to bees, a warning sentence has to be placed on the label.

NL instructions for use the following has to be included:

“Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei

staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen alleen

toepassen tussen zonsondergang en zonsopkomst. “

Other non-target arthropods

In the Annex I first tier risk assessment for non-target arthropods, a low in-field and off-field risk was indicated

by the derived Hazard Quotient values for the standard indicator species T. pyri. However, HQ values for the

other standard (first tier) indicator species A. rhopalosiphi were above the trigger value of 2 for all the

representative field uses – indicating a potential risk. To address this potential risk, a higher tier risk assessment

was conducted in the Annex I evaluation based on the result of extended lab and semi-field studies. However,

this higher tier assessment ‘suggested there is still a high in-field and off-field risk for field uses.

To achieve acceptable risk to non-target arthropods, the following restriction sentence has to be placed on the

WG:

Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te

beschermen is toepassing van het middel in de teelt van sluitkoolachtigen en bloemkoolachtigen (onbedekte

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teelt), wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer uitsluitend toegestaan

wanneer gebruik wordt gemaakt van één van de volgende maatregelen:

- Sleepdoek met minimaal 50% driftreducerende spuitdoppen met inachtneming van een teeltvrije zone

van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de

perceelsgrens/insteek van de sloot).

- lage spuitboomhoogte (maximaal 30 centimeter boven de top van het gewas) met driftarme

Venturidoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone



- conventionele spuit met minimaal 50% driftreducerende spuitdoppen in combinatie met een kantdop en

Hardi TwinForce luchtondersteuning, met inachtneming van een teeltvrije zone van tenminste 200 centimeter

(gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de

sloot).


beschermen is toepassing van het middel in de teelt van aardappelen uitsluitend toegestaan wanneer gebruik

wordt gemaakt van één van de volgende maatregelen:

- Overkapte beddenspuit.


Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 cemtimeter (gemeten

vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).

- Sleepdoek met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het

midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).


luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het


3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point

IIIA 10.6)

Benevia was a representative formulation in the EU review of cyantraniliprole. The intended use pattern for

national authorisation is within the use pattern considered for EU review. Therefore, appropriate assessments

for earthworms and other soil non-target macro-organisms to exposure from Benevia were evaluated as part

of the EU review of cyantraniliprole, where all study references and conclusions can be found.

Earthworms

Based on studies with the active substance and relevant soil metabolites (IN-JCZ38, IN-JSE76, IN-K5A79,

IN-PLT97, IN-J9Z38, IN-K5A77, IN-K5A78, IN-RNU71, and IN-QKV54) TER’s were greater than the

Annex VI criterion.

Effect on other soil non-target macro-organisms

Taking into account that the zRMS has concluded that levels of soil exposure to the active substance and its

metabolites from Benevia’s proposed crop uses are within that already assessed for the representative Annex

I uses (ref. Section B.3.1.5.1 of the Part A ‘Risk management’ Registration report), and that a low and

acceptable risk to earthworms and other soil macro-organisms was concluded in the Annex I evaluation from

these uses, the risk to these soil organisms from the proposed crop uses of ‘Benevia’ will also be acceptable.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point IIIA 10.6)

No significant effects were found on decomposition compared to the controls over the 6-month exposure period

for the active substance or any of the tested metabolites (IN-J9Z38, IN-JCZ38, IN-JSE76, IN-K5A77,

IN-K5A78, IN-K5A79 and IN-PLT97). Therefore, it can be concluded that Benevia poses a low risk to

organisms responsible for organic matter breakdown.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point IIIA 10.7)

Taking into account that zRMS has concluded that levels of soil exposure to the active substance and its

metabolites from Benevia’s proposed crop uses are within that already assessed for the representative Annex I

uses (ref. Section B.3.1.5.1 of the Part A ‘Risk management’ Registration report), and that a low and acceptable

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risk to soil micro-organisms was concluded in the Annex I evaluation from these uses, the risk to soil micro-

organisms from the proposed crop uses of ‘Benevia’ will also be acceptable.

3.1.6.7 Assessment of Potential for Effects on Other Non-Target Organisms (Flora and Fauna)

(Part B, Section 6, Point IIIA 10.8)

Non-target plants

The Annex I evaluation concluded (Section 5, EFSA Conclusion report, 2014) a ‘low risk’ to terrestrial non-

target plants from the proposed field and glasshouse uses of cyantraniliprole – which included use of an

identical formulation to ‘Benevia’ applied via hydraulic boom sprayers in vegetable field crops at rates more

than that proposed for ‘Benevia’.

Therefore, the proposed uses are within the ‘risk envelope’ of the Annex I representative uses and based on this

evaluation a low risk to terrestrial non-target plants may be concluded. No further evaluation is required.

Other non-target species (Flora and Fauna)

Cyantraniliprole is an insecticide and would, therefore, be most active on insect species. There is no indication

from screening studies that would indicate impact on non-target species that are not already apparent from

regulatory testing with cyantraniliprole.

Implications for labelling resulting from ecotoxicological assessment:

In order to protect groundwater this product is not be applied in vegetables or strawberries in groundwater

protection areas.

The following restriction sentence should be added to the WG to protect aquatic organisms, bees and non-target

arthropods:

“Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei


toepassen tussen zonsondergang en zonsopkomst. “















sloot).






Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 centimeter (gemeten







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3.1.7 Efficacy (Part B, Section 7, Point IIIA 6.0)

Preliminary test

Preliminary data were provided for cyantraniliprole on a range of organisms. The activity of cyantraniliprole

was evaluated in screening tests against eight insect species. The product was also screened as a nematicide,

fungicide and herbicide. Some fungicidal effect was observed in the premiminary test, however no instrinstic

activity can be concluded. Thus, no further consideration is therefore required in regard to preliminary data.

Adjuvant is recommended to be used:

The applicant proposed the following wording ‘Use of Adjuvants – The use of suitable, crop safe, oil adjuvants,

can offer enhanced pest control when added to DPX-HGW86 100 g/L OD. For example addition of the rape

seed oil adjuvant, Codacide enhances control of thrips, aphids and whiteflies when applied at a rate up to 2.5

L/ha in field crops’. Codacide is authorised in the Netherlands in 2015, the authroziation number is 13843 N.

The GAP table contains the following wording:

• For ‘Thrips tabaci, Frankiniella occidentalis, Delia antiqua, Anthonomus rubi, Drosophila suzukii:

‘For improved performance use with the addition of a suitable oil adjuvant’.

• For Aleyrodes proletella: ‘Use with the addition of a suitable oil adjuvant’.

zRMS consideres that only for Drosophila suzukii and white fly the addition of an oil-based adjuvant is helpful,

supported current data.

In the Dutch label the following remark is given for Drosophila suzukii and Aleyrodes proletella:

Het middel in combinatie met een uitvloeier op basis van plantaardige olie toepassen.

Minimum Effective Dose

Minimum effective dose (MED) trials were presented on eight pests: Thrips tabaci, Chamaepsila rosae,

Mamestra brassicae, Plutella xylostella, Pieris brassicae, Delia radicum, Aleurodes proletella, and Anthonomus

rubi (and also Leptinotarsa decemlineata, which is being evaluated for CMS, but separately from the UK label).

The applicant has summarised the species on which data are presented as follows, and has argued that these are

the major key species:

Potato

Leptinotarsa decemlineata

Recommended dose: 125ml/ha (12.5g as/ha)

Data from 6 or trials in the Maritime zone (1 Austria, 3 Czech Republic, 2 Germany) are presented.

A slight dose response was seen. Whilst it may be argued the difference between 125 and 100 ml (12.5 and 10 g

a.s)/ha was small, larger differences started to emerge at doses lower than these. Given the economic

importance of Colorado beetle, achieving high levels of control is important, and the dose is considered

justified.

Strawberry

Anthonomus rubi

Recommended dose: 750ml/ha (75g as/ha)

In 2 trials in Poland (North East zone), rates lower than the label dose were applied for control of Anthonomus

rubi.

Drosophila suzukii

recommended dose: 750 ml/ha rate

No trials have been carried out in the Maritime EPPO Zone. The zRMS pointed out that data of Drosophila

suzukii was not provided by the applicant under Minimum Effective Dose section, however there were data

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available of 3 trials in the Mediterranean zone (Spain and Italy) showed no dose response between 60 and 75g

as/ha. NL concluded that the data is not sufficient for authorisation.

Brassicas

Delia radicum


There was no apparent dose response in the single Maritime trial on cauliflower against Delia radicum in the

Netherlands, assessed at 28 days after treatment two.

Results in the 7 trials in the North East zone (Poland) some dose response thought it was not consistent. The

zRMS advised that the proposed minimum effective dose 75 g as/ha is justified. However without any trials in

the Maritime zone it is not possible to justifiy the minimum effective dose in the Netherlands.

Aleurodes proletella


Add a suitable oil type adjuvant, e.g. Codacide at a rate of 2.5 L/ha.

12 trials were carried out on Brussels sprout in comparison to the label recommended rate. Of these, all the

trials were in the Maritime zone (Netherlands, Germany, UK). Dose response was observed with and without

the addition of the oil adjuvant (Codacide).

The trials where Codacide was used, as recommended in the GAP as always necessary for this pest. 75g as/ha

(plus Codacide) as the minimum effective dose is justified.

Lepidoptera


In the RR evaluated by the zRMS, the lower dose of 40-50g as/ha is proposed for Lepidoptera, expressed as a

range to allow grower choice. In the Netherlands only 50g as/ha is claimed.

Mamestra brassicae

Data were presented from one trial in Germany (Maritime), where ‘Benevia 10OD’ was applied at a range of

dose rates (30-50g as/ha) once on cauliflower. Dose response was clear although pest pressure in this trial was

low with only 0.13 larvae per plant. The number of trials is very limited, but according to the Dutch

extrapolation document, it is possible to extrapolate from P. xygostella to P. rapae, C. spectrana, M. brassicae

and E. forficalis. MED for M. brassicae is acceptable.

Plutella xylostella

Data were presented from one trial in the Maritime zone (UK) and 3 trials in the North East zone (Poland),

where ‘Benevia 10OD’ was applied at different doses against Plutella xylostella.

In the one UK trial on head cabbage, no dose response between 30, 40 and 50g as/ha was seen and pest pressure

was very low. In the 3 Polish trials on head cabbage, a marked dose response was observed in all three trials.

In 4 additional trials on cauliflower in the Netherlands, where pest damage (severity) was increased control with

dose was seen in some trials, but results were very variable.

The number of trial in Maritime zone is sufficient, although the result is not constant, considering the all the

trials in Lepidorptera MED for P. xylostella is acceptable.

Pieris brassicae

Data were presented from 6 trials in the Maritime zone (Germany, France, UK) on head cabbage, Brussels

sprout, curly kale and cauliflower, a slight increase in mean control overall with the recommended dose of 40g

as/ha, compared with the lower dose of 30g as/ha, and no clear dose response between 40 g as/ha and 50 g as/ha.

There were an additional 2 trials in Poland (North East zone) where a range of doses was applied, which

supports 40g as/ha as the minimum effective dose on Pieris brassicae, especially in the North East zone.

Minimum effective dose is justified for this use.

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Carrot

Chamaepsila rosae


13 trials were carried out in the Maritime zone (UK, Germany, France and Netherlands). However only in 6

trials of Maritime zone applied the recommended number of treatments (1 or 2). All the other trials applied

more than the recommended number of treatments (3-5). Assessments of pest numbers for the fully supporting

trials were generally made at 61-128 days after the second treatment.

These trials demonstrated that there is a dose response on carrot fly, the proposed minimum effective dose 75g

as/ha is justified.

Bulb and stem (Allium) vegetables

Thrips tabaci


18 trials were carried out on leek and onion. 14 trials were in the Maritime zone (UK, Germany and

Netherlands). Assessments of pest numbers were generally made at 6-10 days after the second treatment,

however for 2 of the trials in the UK this was at 2 days after treatment. Overall some dose response from the

50g as/ha dose to the 75g as/ha dose was observed.

There were 9 trials (in the UK, Netherlands, Germany and Poland) where Codacide was added,

which demonstrate an overall dose response between the 50 and 75gas/ha rates for Thrips tabaci more clearly

than treatments without Codacide.

No evidence has been provided for other target pests on Alliums: Delia antiqua.

Delia antiqua is considered like to be a similar major pest as thrips, the lack of MED data for Delia antiqua

does not support the claim. As bulb vegetables as a group is not a minor use, no extrapolation can be applied to

authorize this use.

Efficacy

Potato

Colorado beetle (Leptinotarsa dece mlineata) LPTNDE

6 trials were carried out on Leptinotarsa decemlineata in the Maritime zone (3 in Czech Republic, 2 in

Germany, 1 in Austria, and 1 in the Netherlands). Control of various life stages was assessed in the trials.

Benevia 10OD showed good efficacy, similar to or better than the standards used in all cases. The claimed use is

supported by the data and can be authorised.

The zRMS noted that “The proposed water volume in the GAP is 150-600 L/ha. However, the lower end of the

range is considered to be low and is not supported by the trials data. The lowest water volume applied in any of

the trials was 300 L/ha. Therefore the recommended range must be amended to 300-600 L/ha.” NL agrees with

the zRMS and the GAP have been amended to 300-600 l/ha. In the Dutch label the following sentences are

added:

In de teelt van aardappel het middel toepassen in 300-600 liter water per ha.

In de teelt van aardbei, wortelgewassen, knolselderij, koolraap, rode biet en schorseneer het middel toepassen in

300-1000 liter water per ha.

In de teelt van bloemkoolachtigen en sluitkoolachtigen het middel toepassen in 300-800 liter water per ha.

Strawberry

Spotted wing drosophila (Drosophila suzukii)

No trials have been carried out in the Maritime EPPO Zone, the South East or North East EPPO zones. There

are therefore no trials that are directly supporting this recommendation in the Central Zone. Data from 3 trials

carried out in the field in the Mediterranean zone were submitted.

At the proposed dose of 75g as/ha, mean control of insect numbers by ‘Benevia 10OD’ was 89.63% (without the

addition of Codacide, and 95.37% with Codacide. No reference product is visible in the RR. The zRMS

recommended that CMS may consider this is sufficient to support an authorisation on strawberry, as spotted

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wing drosophila is an increasing pest of concern, difficult to control, and causes significant economic damage in

a range of fruit crops.

The Netherlands agree with the zRMS that the spotted wing drosophila is an increasing pest of concern, and

difficult to control. However three trials from the Mediteranean zone are not sufficient to support a claim in NL.

Army worm (Spodoptera exigua) and Blossom weevil (Anthonomus rubi)

With these pest-crop conbinations no trials or a limited number of trials are carried out. According the zRMS

extrapolation is not possible and therefore these uses cannot be authorised.

Brassicas (Cauliflower, Broccoli, Cabbage, Brussels sprouts)

Cabbage root fly (Delia radicum)

4 trials were carried out on Brussels sprouts and 1 trial on cauliflower in the Nethelrands. Benevia 10OD

showed comparable or better efficacy than reference products. Noted that the number of trials is limited, the

zRMS considers there is sufficient evidence, considering there are trials on a number of Dipteran pests and

taken together. However, the efficacy in present data was not high enough to justify a claim in NL from 12

central zone trials, and 4 trials in the Maritime zone with an average control of 51% in the Maritime zone. In

addition MED data is not sufficient.

Whitefly (Aleyrodes proletella)

Data from 16 trials in the Maritime zone (9 Netherlands, 1 Germany, 6 United Kingdom). Benevia 10OD

without adjuvant showed variable results and not always comparable/higher than the reference. With the

addition of Codacide the performance Benevia 10OD is cleary enhanced.

The zRMS concluded that “The levels of control achieved when Codacide was added are acceptable for a claim

for whitefly in the Maritime EPPO area of the Central zone”. NL follows this conclusion and an authorization

can be granted.

Lepidoptera

Cabbage moth (Mamestra brassicae)

3 trials were carried out using 50 g/ha dose, in Germany and Netherlands on cauliflower, and in the Netherlands

on red cabbage. Additionally 1 trial with 40 g/ha is carried out in Germany. The summarized data showed that

50 g/ha gives high levels of control of the pest, which is higher than that of reference products. According to the

Dutch extrapolation document, it is possible to extrapolate from P. xygostella to P. rapae, C. spectrana, M.

brassicae and E. forficalis. The trials submitted are sufficient in P. xygostella and therefore this claim can be

extended to the aforementioned species.

Diamondback moth (Plutella xylostella)

Two trials were carried out in the Maritime zone against diamondback moth (1 in the Netherlands on

cauliflower, and 1 in the UK on head cabbage) where insect numbers were assessed. 5 additional trials in the

Maritime zone in the Netherlands, all on cauliflower, where pest damage severity was used as the assessment

criteria. The summarized data showed that 50 g/ha gives high levels of control of the pest, which is higher than

that of reference products. 40 g/ha also gives comparable or higher efficacy than the reference products. This

use can be authorized.

Cabbage white (Pieris brassicae)

Six trials were carried out in the Maritime zone (2 in Germany on head cabbage and cauliflower, 1 in France on

head cabbage, 3 in UK on head cabbage, Brussels sprout and curly kale). At dose of 50 g/ha, used in only 4 of

the 6 trials, mean 99.5% control of cabbage white larvae was recorded (range 97.8-100%). Which is higher than

that of reference products. 40 g/ha also gives comparable or higher efficacy than the reference products. This

use can be authorized.

Silver-Y moth (Autographa gamma)

No trials have been carried out in the Maritime, or Central zone, only the Mediterranean zone 3 trials were

submitted. This claim is insufficient justified, few trials were conducted, and evidence for extrapolation is not

clearly outlined. This species are not justified for extrapolation in NL.

Garden pebble moth (Evergestis forficalis)

No trials data were submitted. However, the applicant would have this claim based on extrapolation from

Plutella xylostella (hardest to control caterpillar) and one other species (e.g. Mamestra brassicae or Pieris

brassicae) to Evergestis forficalis. This is possible based on the EPPO Standard PP 1/257 “Efficacy and crop

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safety extrapolations for minor uses” then authorisation can be recommended Benivia 10OD 50 g a.s./ha

controlling Evergestis forficalis on brassica crops on the basis of extrapolation from other Lepidopteran

caterpillar species.

Cabbage leafroller (Clepsis spectrana)

No trials data were submitted. However, the applicant would have this claim based on extrapolation from

Plutella xylostella (hardest to control caterpillar) and one other species (e.g. Mamestra brassicae or Pieris

brassicae) . This is possible based on the EPPO Standard PP 1/257 “Efficacy and crop safety extrapolations for

minor uses” then authorisation can be recommended Benivia 10OD 50 g a.s./ha controlling Clepsis spectrana on

brassica crops on the basis of extrapolation from other Lepidopteran caterpillar species.

Army worm (Spodoptera exigua) and sawfly (Athalia rosae)

With these pest-crop conbinations no trials are carried out. According the zRMS extrapolation is not possible

and therefore these uses cannot be authorised.

Carrot

Carrot fly (Chamaepsila rosae)

17 trials were carried out in Maritime zone (5 in UK, 7 in Netherlands, 3 in Germany, 2 in France). Only 7 trials

had the recommended number of 2 treatments or less (5 UK, 1 Netherlands, 1 Germany). In these trials Benevia

10OD 75 g/ha performed consistently better than the reference products. Extrapolation is possible from carrot

fly on carrot to ‘all umbelliferous crops’. NL considers the claimed use can be authorized; on carrots, parsnips,

celeriac, hamburg root parsley and skirret.

Bulb and stem vegetables (Onion, shallots, Garlic, Leek, spring onion)

Onion thrips (Thrips tabaci)

18 trials were assessed for control of Thrips tabaci on leek and onion, among which, 14 were done in the

Maritime zone (8 in Netherlands on leek, 3 UK on leek, 2 UK on onion, 1 in Germany on onion). The overall

mean value damostrated moderate (and variable) control on insect number and crop damage, which is slightly

higher or comparable efficacy than reference products. Addition of adjuvant codacide did not increase the

efficacy. The Dutch authorization protocol does not allow for a claim for 'moderate control' on the label as

given on the ZRMS label. The mean control from all life stages of this pest was roughly 50-60%. Based on

expert judgement and knowlegde of the reference products which show the same efficacy and variability, a

claim for use against T. tabaci in onions in the Netherlands is acceptable.

Onion fly (Delia antiqua)

6 trials were carried out in the Maritime zone (Netherlands) on garden onions/scallions and pearl onions. the

aggregated data showed a good level of control with a mean of 89.4% reduction in pest damage. However,

zRMS poined out that “trials were all assessed at different timings and had different numbers of treatments, and

this aggregated figure has little value. Treatment timings were between April and July. Assessments were

mainly made 52-162 days after the last application.” Only in 2 trials the results were collected after the

proposed number of 2 treatments. These showed 96.6% reduction in pest damage at 1DAT, 100% at 21 DAT

(bulb), and 94.4% at 162 DAT. The trial number is considered limited and insufficient for authorization. As

bulb vegetables as a group is not a minor use, no extrapolation can be applied to authorize this use.

Onion leaf miner (Phytomyza gymnostoma)

Two trials were carried out in the Maritime zone on leek. The trial number is considered limited and insufficient

for authorisation. As bulb vegetables as a group is not a minor use, no extrapolation can be applied to authorise

this use.

Effects on yield and quality

Yield and quality was assessed in some of the efficacy trials on leek and oinion, and cabbage. No negative

effects on yield quality/potential after application of cyantraniliprole 100 g/l OD (with or without the adjuvant

Codacide oil) were observed in any trial. In some of the trials Cyantraniliprole at proposed dose rate applied

alone or in mixture with Codacide oil tended to increase the proportion of the crop that was marketable relative

to the untreated, or improve the crop colour.

Effects on the processing procedure

Taint tests on cyanatraniliprole were still carried out on claimed crops including tomato (ketchup, canned),

potato (quick frozen), strawberry (jam, fresh), carrot (canned), cabbage (pickled), olives (in oil). The results

Benevia Part A


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showed that there was no taint on a range of vegetable and other crops in any of the tests when cyantraniliprole

was applied at up to 120g as/ha in as a commercial formulation containing 100 g a.s./l (with or without

Codacide oil as recommended on the label). Some of the tests identified a sensory difference, however this was

not described in more detail in the BAD or dRR, and is not regarded as taint.

Phytotoxicity to host crop

The applicant has provided phytotoxicity data from 117 trials on 12 different crops. In 101 efficacy trials

phytotoxicity symptoms were assessed. Additionally 16 phytotoxicity trials were carried out. No phytotoxic

symptoms were observed for the product in mixture with Codacide at any assessment.

No phytotoxicity trials were carried out on salad onion, shallot, garlic or parsnip. However, extrapolation is

possible from leek, onion and carrot.

Adverse effects on parts of plant used for propagating purposes

Based on the extensive crop safety data set showing no phytotoxic effects, safety to propagating material is

considered to be satisfactorily addressed.

Impact on succeeding crops

No risk to succeeding crops is expected , no specific restrictions required.

Impact on other plants including adjacent crops

Sufficient information is provided. No warnings regarding adjacent crops are required.

Possible development of resistance or cross-resistance

Cyantraniliprole is a ryanodine receptor modulator, belonining to the group of anthranilic diamide. The IRAC

code is 28. The applicant provided an extensive analysis on resistance development. A few cases of resistance to

diaminde insecticides have been reported in Asia-Pacific, Latin America, and North America. The applicant

stated that so for no resistance cases has been reported in Europe. The mechanism of resistance was explained

(metabolic, penetration and behavioural). Field monitoring and lab experiments showed no cross resistance.

Overall, the resistance risk can be concluded as high for many of the recommended pests. In the Dutch label the

following warning is included:

Resistentiemanagement:

Dit middel bevat de werkzame stof cyantraniliprole. Cyantraniliprole behoort tot de ryanodine receptor

modulators. De Irac code is 28.

Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de

adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

3.2 Conclusions

The assessment conducted for Benevia was in accordance with the Uniform Principles and demonstrates an

acceptable risk to human health and the environment. An authorisation can therefore be granted except for the

use in strawberry, the uses against Lepidoptera (Spodotera exigua and Autographa gamma), Hymenoptera

(Athalia rosae) and Diptera (Delia radicum) in cauliflower, broccoli, head cabbage and Brussels sprout and the

uses against Diptera (Delia antiqua) and Leafminer (Phytomyza gymnostoma) in bulb vegetables and stem

vegetables due to unsufficient efficacy data. Furthermore, the use on leek cannot be authorised unless the

current MRL is raised.

3.3 Substances of concern for national monitoring

Cyantraniliprole is not a substance of concern for national monitoring.

3.4 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation

None.

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3.5 Legal instructions

As of January 1st 2018 an amendment of the Activity Decree has come into force, some of the restriction

sentences that have been included on the Legal Instructions will become unnecessary or change. Therefore the

following sentences will be included on the Legal instructions:

Om residuen in voedings- of voedergewassen ten gevolge van ophoping van persistente bodemmetabolieten te

voorkomen, is het gebruik van dit product beperkt tot 2 toepassingen per jaar volgens het gebruiksvoorschrift.

Dit product, of andere producten die cyantraniliprole bevatten, mogen gedurende hetzelfde jaar niet nogmaals

op hetzelfde perceel worden toegepast.

In de teelt van knolselderij maximaal 1,5 L/ha middel per teeltcyclus toepassen.

In de teelt van aardappel het middel toepassen in 300-600 liter water per ha.

In de teelt van wortelgewassen, knolselderij, koolraap, rode biet en schorseneer het middel toepassen in 300-

1000 liter water per ha.

In de teelt van bloemkoolachtigen en sluitkoolachtigen het middel toepassen in 300-800 liter water per ha.

Om het grondwater te beschermen mag dit product in de teelt van sluitkoolachtigen, bloemkoolachtigen,

wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer niet worden gebruikt in

grondwaterbeschermingsgebieden.

Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei


toepassen tussen zonsondergang en zonsopkomst.















sloot).






Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 centimeter (gemeten







Resistentiemanagement:

Benevia Part A


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Dit middel bevat de werkzame stof cyantraniliprole. Cyantraniliprole behoort tot de ryanodine receptor

modulators. De Irac code is 28.

Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de

adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

Benevia Part A


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APPENDIX 1

COPY OF THE PROPOSED PRODUCT LABEL

Wettelijk Gebruiksvoorschrift Het middel is uitsluitend toegelaten als insectenbestrijdingsmiddel voor het professionele gebruik door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0 Ctgb juni 2011) onder de hierna vermelde toepassingsvoorwaarden Toepassingsvoorwaarden:

Toepassingsgebied

Werkzaamheid getoetst op

Maximale dosering* middel per toepassing

Maximaal aantal toepassingen per teeltcyclus

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen

Aardappelen kevers1 0,125 L/ha 2 7 14

Sluitkoolachtigen (onbedekte teelt)

rupsen 2,3,4,5,6 0,5 L/ha 2

7

7

wittevlieg7 **

0,75 L/ha

Bloemkoolachtigen (onbedekte teelt)

rupsen 2,3,4,5,6 0,5 L/ha 2

7

7

wittevlieg7 ** 0,75 L/ha

Wortelgewassen (onbedekte teelt)

vliegen en muggen8 0,75 L/ha 2 10 14

Knolselderij (onbedekte teelt)

vliegen en muggen8 0,75 L/ha 2 10 14

Ui-achtigen (onbedekte teelt)

Trips9 0,75 L/ha 2 7 14

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen. ** Het middel in combinatie met een uitvloeier op basis van plantaardige olie toepassen. 1 Coloradokever (Leptinotarsa decemlineata) 2 kooluil (Mamestra brassica) 3 Pieris soorten (Pieris spp.) 4 late koolmot (Evergestis forficalis) 5 koolbladroller (Clepsis spectrana)

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6 koolmot (Plutella xylostella) 7 koolwittevlieg (Aleyrodes proletella) 8 wortelvlieg (Chamaepsila rosae) 9 tabakstrips (Thrips tabaci). Het gebruik in de teelt van koolraap, rode biet, knolselderij en schorseneer is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en verantwoordelijkheid van de gebruiker.

Toepassingsgebied Werkzaamheid aannemelijk tegen

Maximale dosering* middel per toepassing

Maximaal aantal toepassingen per teeltcyclus

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen

Koolraap (onbedekte teelt)

rupsen2,3 0,5 L/ha 2 10 14

Rode biet (onbedekte teelt)

rupsen2,3 0,5 L/ha 2 10 14

Knolselderij (onbedekte teelt)

rupsen2,3 0,5 L/ha 2 10 14

Schorseneer (onbedekte teelt)

rupsen2,3 0,5 L/ha 2 10 14

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. 2 kooluil (Mamestra brassica) 3 Pieris soorten (Pieris spp.) Overige Toepassingsvoorwaarden Om residuen in voedings- of voedergewassen ten gevolge van ophoping van persistente bodemmetabolieten te voorkomen, is het gebruik van dit product beperkt tot 2 toepassingen per jaar volgens het gebruiksvoorschrift. Dit product, of andere producten die cyantraniliprole bevatten, mogen gedurende hetzelfde jaar niet nogmaals op hetzelfde perceel worden toegepast. In de teelt van knolselderij maximaal 1,5 L/ha middel per teeltcyclus toepassen. In de teelt van aardappel het middel toepassen in 300-600 liter water per ha.

Benevia Part A


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In de teelt van wortelgewassen, knolselderij, koolraap, rode biet en schorseneer het middel toepassen in 300-1000 liter water per ha. In de teelt van bloemkoolachtigen en sluitkoolachtigen het middel toepassen in 300-800 liter water per ha. Om het grondwater te beschermen mag dit product in de teelt van sluitkoolachtigen, bloemkoolachtigen, wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer niet worden gebruikt in grondwaterbeschermingsgebieden. Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen alleen toepassen tussen zonsondergang en zonsopkomst. Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te beschermen is toepassing van het middel in de teelt van sluitkoolachtigen en bloemkoolachtigen (onbedekte teelt), wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer uitsluitend toegestaan wanneer gebruik wordt gemaakt van één van de volgende maatregelen: - Sleepdoek met minimaal 50% driftreducerende spuitdoppen met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). - lage spuitboomhoogte (maximaal 30 cm boven de top van het gewas) met driftarme Venturidoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). - conventionele spuit met minimaal 50% driftreducerende spuitdoppen in combinatie met een kantdop en Hardi TwinForce luchtondersteuning, met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te beschermen is toepassing van het middel in de teelt van aardappelen uitsluitend toegestaan wanneer gebruik wordt gemaakt van één van de volgende maatregelen: - Overkapte beddenspuit - lage spuitboomhoogte (maximaal 30 cm boven de top van het gewas) met driftarme Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot) - Sleepdoek met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot) - conventionele spuit met minimaal 75% driftreducerende spuitdoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). Resistentiemanagement:

Benevia Part A


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Dit middel bevat de werkzame stof cyantraniliprole. Cyantraniliprole behoort tot de ryanodine receptor modulators. De Irac code is 28. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

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APPENDIX 2

DATA PROTECTION CLAIMS IN THE NETHERLANDS

ANNEX III STUDIES

Annex point

Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Data protection claimed Y/N

Data protection granted Y/N

Owner

KIIIA, 2.7.5/01 2011 DPX-HGW86 100 g/liter OD oil

dispersion (oil-bases suspension concentrate) formulation (in PET

container): Laboratory study of

shelf-life stability (3 years) Advinus Therapeutics Limited DuPont-25620

Final

GLP: Yes Published: No

Y Y FMC

KIIIA, 2.7.5/02 2012 DPX-HGW86 100 g/L OD oil

dispersion (oil-based suspension

concentrate) formulation (in PV/EVOH container): Laboratory study of

shelf-life stability Advinus Therapeutics

Limited DuPont-21308 Final GLP: Yes Published: No

Y Y FMC

KIIIA, 5.2.1/01

2013 Validation of the analytical method for

the determination of cyantraniliprole

(DPX-HGW86) in DPX-HGW86 end-use products

DuPont Stine-Haskell Research Center

DuPont-37394 and DuPont-37394 confidential attachment GLP: Yes

Published: No

Y Y FMC

KIIIA, 5.2.1/02 2013 Determination of cyantraniliprole (DPX-

HGW86) in DPX-HGW86 end-use product DuPont Stine-Haskell Research

Center DuPont-35229, Revision No. 1

GLP: No Published: No

N Y FMC

KIIIA, 5.2.4/01 2014 Description and validation of the

analytical method for determination of

IN-Q6S09 in cyantraniliprole (DPX-HGW86) end-use products


DuPont-39012, Revision No. 1 GLP: Yes Published: No

Y Y FMC

KIIIA, 5.2.4/02 2014 Description of validation of the


IN-RYA13 in cyantraniliprole (DPX-HGW86) end-use products



Y Y FMC

KIIIA, 5.2.4/03 2014 Description of validation of the


acetonitrile, n-hepane, and 3-picoline in cyantraniliprole (DPX-HGW86) end-use

products MPI Research, Inc. DuPont-41064 GLP: Yes Published: No

Y Y FMC

KIIIA, 5.2.4/04 2017 Description and validation of the

analytical methods for determination of

methanesulfonic acid in cyantraniliprole (DPX-HGW86) end-use products

DuPont-46998


Y Y FMC

Benevia Part A


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Annex point




Owner

KIIIA,

8.3.2/01

2012 Magnitude and decline of

cyantraniliprole and metabolite residues in green onion and dry bulb onion (bulb

vegetables) following foliar application

of DPX-HGW86 100 g/L OD - Europe - 2010 initiation Charles River

Laboratories (UK) DuPont-29225 GLP:

Yes Published: No

Y Y FMC

KIIIA, 8.3.2/02 2012 Magnitude and decline of DPX-HGW86 and metabolite residues in leeks (stem

vegetables) following foliar application

of DPX-HGW86 100 g/L OD - Europe - 2010 initiation

Charles River Laboratories (UK) DuPont-29955 GLP: Yes Published: No

Y Y FMC

KIIIA, 8.3.3/01

2013 Magnitude and decline of

cyantraniliprole (DPX-HGW86) and

metabolite residues in strawberries (berries and small fruit) following foliar

application of DPX-HGW86 100 g/L

OD - Europe - 2011 Initiation Charles River Laboratories (UK) DuPont-29223


Y Y FMC

KIIIA, 8.3.4/01 2013 Magnitude and decline of

cyantraniliprole (DPX-HGW86) and metabolite residues in carrots (root and

tuber vegetables) following foliar

application of DPX-HGW86 100 g/L OD - Europe - 2011 initiation Charles

River Laboratories (UK) DuPont-32187


Y Y FMC

KIIIA, 8.3.6/01

KIIIA, 8.5.4.1/01

2014 Combined processing and magnitude

and decline of cyantraniliprole (DPX-

HGW86) and metabolite residues in cauliflower/broccoli, Brussels sprouts,

and cabbage (flowering and head

brassica vegetables) following foliar application of DPX-HGW86 100 g/L

OD and soil application of DPX

HGW86 200 g/L SC - Europe - 2012 initiation Charles River Laboratories

(UK)

DuPont-34095 GLP: Yes Published: No

Y Y FMC

KIIIA, 9.1/01 2017 Rate of degradation of [14C]IN-M2G98 in five soils

Wildlife International Ltd (USA)

DuPont-47642 GLP: Yes

Published: No

Y Y FMC

KIIIA, 9.2.1/01 2012 Derivation of modelling DT50 of

cyantraniliprole (DPX-HGW86) and its metabolites from terrestrial field

dissipation study following FOCUS kinetics guidance DuPont Stine-Haskell

Research Center DuPont-33684 EU


N Y FMC

KIIIA, 9.2.1/02 2014 Derivation of modelling DT50 of cyantraniliprole (DPX-HGW86) and its

metabolites from terrestrial field

dissipation studies following FOCUS kinetics guidance Supplement No. 1:

Refined kinetic fits for IN-JSE76 and

IN-K5A78 DuPont Stine-Haskell Research Center

DuPont-33684 EU, Supplement No. 1


N Y FMC

Benevia Part A


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Annex point




Owner

KIIIA, 9.2.1/03 2014 Evaluation of cyantraniliprole (DPX-

HGW86) field dissipation studies in North America and Europe following

the EFSA (2014) guidance Waterborne

Environmental, Inc. (WEI) DuPont-41056, Revision No. 1 GLP: No

Published: No

N N FMC

KIIIA, 9.2.1/04 2016 The field soil dissipation of DPX-

HGW86 following a single application to bare ground - UK 2015

Charles River Laboratories (UK)

DuPont-43619 IM GLP: Yes

Published: No

Y Y FMC

KIIIA, 9.2.1/05 2017 Degradation of cyantraniliprole (DPX-HGW86) in the field dissipation study

conducted in the United Kingdom - a

kinetic calculation report Waterborne Environmental, Inc. (WEI)

DuPont-47676 EU


N N FMC

KIIIA, 9.3/01 2017 [14C]IN-M2G98: Batch equilibrium

(adsorption/desorption) in five soils

EAG Laboratories DuPont-47641

GLP: Yes

Published: No

Y Y FMC

KIIIA, 9.4/01

KIIIA, 9.5/01

2014 Predicted environmental concentrations

of cyantraniliprole (DPX-HGW86) and

its metabolites in soils GVK Biosciences Private Limited, DuPont Stine-Haskell

Research Center DuPont-41063 EU


N N FMC

KIIIA, 9.6/01 2014 Evidences for plant uptake of cyantraniliprole (DPX-HGW86) by

crops from soils under greenhouse and

field conditions DuPont Stine-Haskell Research Center DuPont-39549 EU


N N FMC

KIIIA, 9.6/02 2014 Leaching behaviour of the OD

formulation of cyantraniliprole (DPX HGW86) and its metabolites - a

modeling study conducted with the

endpoints recommended by UK CRD and derived from field dissipation

studies

GVK Biosciences Private Limited DuPont Stine-Haskell Research Center

DuPont-38334 EU GLP: No Published:

No

N N FMC


formulation of cyantraniliprole (DPX

HGW86) and its metabolites - a modeling study conducted with the

endpoints recommended by UK CRD

and derived from field dissipation studies

GVK Biosciences Private Limited

DuPont Stine-Haskell Research Center DuPont-38334 EU, Supplement No. 1


N N FMC

Benevia Part A


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Annex point




Owner

KIIIA, 9.6/04

2013 Soil pH range of arable land by member

state in Europe Dr. Knoell Consult GmbH, DuPont

Stine-Haskell Research Center DuPont-

36136 EU GLP: No Published: No

N N FMC

KIIIA, 9.7/01 KIIIA, 9.8/01

2014 Predicted environmental concentrations of cyantraniliprole (DPX-HGW86) and

its soil and water metabolites in surface

water and sediment following applications of the OD formulation - a

modeling study conducted with the

endpoints recommended in the EFSA Conclusion Dr. Knoell Consult GmbH,

DuPont Stine-Haskell Research Center DuPont-38329 EU GLP: No Published:

No

N N FMC


formulation of cyantraniliprole (DPX-HGW86) and its metabolites - a

modeling study conducted for the

Netherlands with GeoPEARL 3.3.3 GVK Biosciences Private Limited


DuPont-37848 NL GLP: No Published: No

N N FMC

KIIIA, 9.6/06 2017a Leaching behaviour of the OD

formulation of cyantraniliprole (DPX-

HGW86) and its metabolites - a modeling study conducted for the

Netherlands with GeoPEARL 3.3.3

Supplement no.1: additional modeling with multiple application dates

Excelra Knowledge Solutions Private

Limited DuPont Stine-Haskell Research Center

DuPont-37848 NL, Supplement No. 1


N N FMC

KIIIA, 9.6/07 2017b Leaching behaviour of the OD

formulation of cyantraniliprole (DPX-

HGW86) and its metabolites - a modeling study conducted for the

Netherlands with GeoPEARL 3.3.3

Supplement no.2: refined modeling for IN-M2G98

Excelra Knowledge Solutions Private

Limited DuPont Stine-Haskell Research Center

DuPont-37848 NL, Supplement No. 2


N N FMC

KIIIA, 9.6/08 2017 Cyantraniliprole 625 g/l FS Registration Report part B section 8: Assessment of

the relevance of metabolites in

groundwater - detailed summary of the risk assessment

DuPont

DuPont-36028 EU, Revision No. 1 GLP: No Published: No

N N FMC

KIIIA, 9.6/09 2017 IN-K5A79: Bacterial Reverse Mutation

Test DuPont Haskell Global Centers for

Health & Environmental Sciences

DuPont-44973 Revision 1 GLP: Yes Published: No

Y Y FMC

Benevia Part A


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Annex point




Owner

KIIIA, 9.6/10 2015 IN-K5A79: In Vitro Mammalian

Chromosome Aberration Test in Human Peripheral Blood Lymphocytes

DuPont Haskell Global Centers for

Health & Environmental Sciences DuPont-44974


Y Y FMC

KIIIA, 9.6/11 2015 IN-K5A79: In Vitro Mammalian Cell

Forward Gene Mutation (CHO/HPRT) Assay with

Duplicate Cultures

BioReliance Corporation DuPont-44975


Y Y FMC

KIIIA, 9.6/12 2017 IN-K5A78: Bacterial Reverse Mutation Test




Y Y FMC

KIIIA, 9.6/13 2015 IN-K5A78: In Vitro Mammalian

Chromosome Aberration Test in Human Peripheral Blood Lymphocytes




Y Y FMC

KIIIA, 9.6/14 2015 IN-K5A78: In Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT)

Assay with

Duplicate Cultures BioReliance Corporation

DuPont-45115


Y Y FMC

KIIIA, 9.6/15 2017 IN-K5A79: Acute Oral Toxicity Study in Rats - Up-and- Down Procedure

DuPont Haskell Global Centers

for Health & Environmental Sciences DuPont-45251, Revision 1


Y Y FMC

KIIIA, 9.6/16 2016 IN-K5A79: Repeated-Dose Oral

Toxicity 28-Day Feeding Study in Rats

DuPont Haskell Global Centers

for Health & Environmental Sciences DuPont-45276 VO1 & VO2


Y Y FMC

KIIIA, 9.6/17 2017 Leaching behaviour of cyantraniliprole (DPX-HGW86) and its metabolite IN-

M2G98 in Europe: Refined modeling

study conducted for SC, OD, SE and FS

formulations

Excelra Knowledge Solution Private Limited

DuPont-47675 EU


N N FMC

KIIIA,9.6/18 2017 Degradation of cyantraniliprole (DPX-HGW86) in the field dissipation study

conducted in the United Kingdom – a

kinetic calculation report Waterborne Environmental, Inc. (WEI)

DuPont-47676 EU


N N FMC

Benevia Part A


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Annex point




Owner

KIIIA, 9.7/02

KIIIA, 9.8/02

2014 Predicted environmental concentrations

of the OD formulation of cyantraniliprole (DPX-HGW86) and its

metabolites in surface water and

sediment following applications to various crops in the Netherlands: A

modelling study using TOXSWA 1.2

and DROPLET 1.1 Dr. Knoell Consult GmbH, DuPont DuPont-36651 NL GLP:

No Published: No

N N FMC

KIIIA, 10.2.2.2/01 2014 Cyantraniliprole (DPX-HGW86)

technical: A 48-hour static-renewal acute toxicity test with Hyalella Azteca

Wildlife International Ltd. (USA) DuPont-37852 GLP: Yes Published: No

Y Y FMC

KIIIA, 10.4/01 2011 Cyantraniliprole: Honeybee risk

assessment DuPont de Nemours

(Deutschland) GmbH DuPont-31516 EU, Revision No. 1 GLP: No Published:

No

N N FMC

KIIIA, 10.4.6/01 2011 Data supporting insignificant exposure

of cyantraniliprole and its metabolites to honey bees from uptake of soil residues


Laboratories DuPont-30776 EU GLP: No Published: No

N N FMC

KIIIA, 6.0/01

KIIIA, 6.0/02

2014 Cyantraniliprole 100 g/L OD, 100 g/L

oil in water dispersion (OD): Biological assessment dossier (Central zone) E. I.

du Pont de Nemours and Company

DuPont-37256 CEU GLP: No Published: No

N N FMC

KIIIA, 6.1/01 2014 DPX-HGW86 100 g/L OD: Trial reports

efficacy, selectivity and yield (Central

zone) DuPont de Nemours (France) S.A.S. DuPont-43004 CEU GEP: Yes

Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIIA,1.4.1/01 2011 Product identity and compostion of end-

use product DPX-HGW86 100 g/L OD DuPont Stine-Haskell Research Center

DuPont-24546, Revision No.2 and

DuPont-24546 Revision No. 2 confidential attachment GLP: No

Published: No

Y Y FMC

IIIA, 2.1/01 2009 Cyantraniliprole (DPX-HGW86) 100 g/Liter OD oil-based suspension

concentrate formulation: Summary

report of laboratory study of physical and chemical characteristics Advinus

Therapeutics Private Limited, Chilworth

Technology Ltd. DuPont-21817 GLP: No Published: No

Y Y FMC

IIIA, 2.1/02 2008 DPX-HGW86 100 g/Liter OD oil

dispersion (oil-based suspension

concentrate) formulation: Laboratory study of physical and chemical

properites Advinus Therapeutics Private

Limited DuPont-21307 GLP: Yes Published: No

Y Y FMC

IIIA, 2.2.1/02 2009 Cyantraniliprole 100 g/Liter OD Oil

dispersion (oil-based suspension concentrate) formulation

(DPX-HGW86): Laboratory study of

flash point, explosive properties and auto-ignition temperature of liquids

Chilworth Technology Limited DuPont-

21816 GLP: Yes Published: No

Y Y FMC

IIIA, 2.13/01 2010 Cyantraniliprole (DPX-HGW86) 100

g/liter OD oil-based suspension

concentrate formulation: Laboratory study of storage stability and corrosion

characteristics International Institute of

Biotechnology and Toxicology (IIBAT) DuPont-21553 GLP: Yes Published:

No

Y Y FMC

IIIA, 4.2.2/01 2010 Cyantraniliprole 100 g/Liter OD:

Laboratory study of spray tank cleanout International Institute of Biotechnology

and Toxicology (IIBAT) DuPont-29886


Y Y FMC

IIIA, 7.1.1/01 2008 DPX-HGW86 100 g/L OD: Acute oral

toxicity - up and down procedure in rats


Y Y FMC

IIIA, 7.1.2/01 2008 DPX-HGW86 100 g/L OD: Acute

dermal toxicity study in rats DuPont-


Y Y FMC

IIIA, 7.1.3/01 2009 Cyantraniliprole (DPX-HGW86)

100 g/L OD: Inhalation median lethal

concentration (LC50) study in rats DuPont-27807 Revision No. 1 GLP:

Yes Published: No

Y Y FMC

IIIA, 7.1.4/01 2006 DPX-HGW86 100 g/L OD: Acute dermal irritation study in rabbits

DuPont-19079 GLP: Yes Published:

No

Y Y FMC

IIIA, 7.1.5/01 2006 DPX-HGW86 100 g/L OD: Acute eye irritation study in rabbits DuPont-19080


Y Y FMC

IIIA, 7.1.6/01 2006 DPX-HGW86 100 g/L OD: Local lymph node assay (LLNA) in mice

DuPont-19081 GLP: Yes Published:

No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIIA, 7.1.6/02 2009 DPX-HGW86 100 g/L OD: Dermal

sensitization test - Buehler method DuPont-22769, Revision No. 1 GLP:

Yes Published: No

Y Y FMC

IIIA, 7.6.1/01 2008 Cyantraniliprole (DPX-HGW86) 100 g/L OD: In vivo dermal absorption

of cyantraniliprole in rat DuPont-24503


Y Y FMC

IIIA, 7.6.2/01 2008 Cyantraniliprole (DPX-HGW86) 100 g/L OD: In vitro kinetics of

cyantraniliprole in rat and human skin


Y Y FMC

IIIA, 9.4/01 2010 The degradation of cyantraniliprole

(DPX-HGW86) and metabolites in aerobic soil - summary of kinetic

calculations Waterborne

Environemental, Inc. (WEI) DuPont-29554, Revision No. 2 GLP:

Not given Published: No

Y Y FMC

IIIA, 9.4/02 2010 Predicted environmental concentrations

of cyantraniliprole (DPX-HGW86) and its metabolites in soil Simulogic

Environmental Consulting Pvt. Ltd.

DuPont-29548 EU GLP: No Published: No

Y N FMC

IIIA, 9.6/01 2011 Tier 1 groundwater and surface water

and Tier 2 surface water exposure assessment of cyantraniliprole

(DPX-HGW86) and its metabolites in

the United States Waterborne Environmental, Inc. DuPont-29549


Y N FMC

IIIA, 9.6/02 2010 Leaching behaviour of the OD formulation of cyantraniliprole

(DPX-HGW86) and its metabolites - a

modeling study conducted with FOCUS PELMO 3.3.2 and FOCUS PEARL

3.3.3 Simulogic Environmental

Consulting Pvt. Ltd. DuPont-29249 EU GLP: No Published: No

Y N FMC

IIIA, 9.6/03 2010 The degradation of cyantraniliprole

(DPX-HGW86) in aquatic systems, via

photolysis and in anaerobic soil - summary of kinetic calculations DuPont

Stine-Haskell Research Center DuPont-

29552 GLP: No Published: No

Y Y FMC

IIIA, 9.7/01 2011 Predicted concentrations of

cyantraniliprole - OD formulation

(DPX-HGW86), and its metabolites in surface waters in Europe - a modeling

study conducted with FOCUS surface

water scenarios Simulogic Environmental Consulting Pvt. Ltd.

DuPont-29252, Revision No. 1 GLP:

No Published: No

Y N FMC

IIIA, 10.1.6/01 2009 Cyantraniliprole 100 g/L OD: An acute

oral toxicity study with the northern

bobwhite (Colinus virginianus) Wildlife International, Ltd. DuPont-24484


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIIA, 10.2.2.1/01 2009 Cyantraniliprole (DPX-HGW86)

100 g/L OD: A 96-hour static acute toxicity test with the bluegill

(Lepomis macrochirus) Wildlife

International, Ltd. DuPont-26581 GLP: Yes Published: No

Y Y FMC

IIIA, 10.2.2.2/01 2006 DPX-HGW86 100 g/L OD: Static,

acute, 48-hour toxicity test to Daphnia magna DuPont Haskell

Laboratories DuPont-19853 GLP: Yes

Published: No

Y Y FMC

IIIA, 10.2.2.2/02 2010 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus codacide, oil: Static,

acute, 48-hour toxicity test with the

cladoceran, Daphnia magna DuPont Haskell Laboratories; Critical Path

Services, LLC (CPS) DuPont-29051


Y Y FMC

IIIA, 10.2.2.3/01 2009 Cyantraniliprole (DPX-HGW86)

100 g/L OD: A 72-hour toxicity test

with the freshwater alga, Pseudokirchneriella subcapitata

Wildlife International, Ltd.


Y Y FMC

IIIA, 10.5/01 2011 Cyantraniliprole: Non-target arthropod

risk assessment for the EU DuPont de Nemours (Deutschland) GmbH DuPont-

31525 EU GLP: Not applicable -

position paper Published: No

Y Y FMC

IIIA, 10.6.2/01 2008 DPX-HGW86 100 g/L OD: Acute toxicity to the earthworm, Eisenia fetida

in artificial soil International Institute of

Biotechnology and Toxicology (IIBAT) DuPont-24879 GLP: Yes Published:

No

Y Y FMC

IIIA, 10.6.3/01 2010 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus codacide oili: Effects

on reproduction and growth of the

earthworm, Eisenia fetida, in artificial soil with 5% peat Institut fur

Biologische Analytik und Consulting

IBACON GmbH DuPont-29052 GLP: Yes Published:

No

Y Y FMC

IIIA, 10.7.1/01 2008 Cyantraniliprole (DPX-HGW86)

100 g/L OD: Assessment of the effects on soil microflora Institut fur

Biologische Analytik und Consulting

IBACON GmbH DuPont-24875 Revision No. 1 GLP:

Yes Published: No

Y Y FMC

Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

6.0

Mode of action of cyantraniliprole

and implications on the selection of

efficacy data presented. Internal

position paper.

DuPont N N Y Y Y 201

6

DuPont-

46963

6.0 Cyantraniliprole active substance

Labels and leaflets DuPont N N Y Y Y

201

3

DP-

27752

6.0

Laboratory evaluation of time to

stop feeding for DPX-E2Y45

35WG, DPX-HGW86 10OD,

indoxacarb 30WG and competitive

products on 2nd instar Mamestra

brassicae larvae, on cabbage leaves

DuPont

ERDC,

FR

N N Y Y Y 200

9 I-09-001

6.0


stop feeding and time to kill of

DPX-E2Y45 35WG, DPX-HGW86

10OD, DPX-MP062 30WG,

methomyl 20L vs. competitive

products on 2nd and 4th instar

Helicoverpa armigera larvae on

cotton leaves.

DuPont

ERDC,

FR

N N Y Y Y 201

1 I-11-008

6.0


kill of DPX-E2Y45 20SC and

DPX-HGW86 10OD vs. competitor

products on Leptinotarsa

decemlineata on potato leaves


1 I-11-020

6.0

Laboratory evaluation of time for

feeding cessation of various

feeding stages of Leptinotarsa

decemlineata exposed to potato

leaves treated with DPX-E2Y45

20SC, DPX-HGW86 10OD or

competitive products


1 I-11-021

6.0

Laboratory evaluation of the

residual activity of DPX-E2Y45

35WG, DPX-HGW86 10OD and

indoxacarb 30WG on Helicoverpa

armigera on tomato, in comparison

with competitors (methoxyfenozide

and metaflumizone).


9 I-09-003

6.0

Evaluation of potency and residual

performance of DPX-E2Y45

35WG and DPX-HGW86 10OD

used straight or with 0.25%v/v of

Codacide® on Helicoverpa

armigera eggs.


1 I-11-006

6.0

Laboratory evaluation of Lannate®

20L (methomyl), DPX-E2Y45

35WG, DPX-HGW86 10OD and

Talstar® Flo (bifenthrin) applied

by direct spray on Helicoverpa


0 I-10-004

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

armigera adults.

6.0

Larvae instars sensitivity of

Helicoverpa armigera to DPX-

HGW86 10OD in laboratory

conditions.


2 I-12-001

6.0

Laboratory evaluation of the

potency of DuPont Insecticides

Portfolio on Tuta absoluta, activity

on different stages of the insect.


2 I-11-501

6.0

Potency of DPX-E2Y45 20Sc and

DPX-HGW86 10OD against

Leptinotarsa decemlineata adults

on potato plants in laboratory

conditions.


3 I-13-001

6.0 Cyazypyr™ translaminar activity

on Myzus persicae on pepper DuPont N N Y Y Y

200

8 I-08-001

6.0 Evaluation of Cyazypyr™ and

Rynaxypyr™ potency on

Leptinotarsa decemlineata larval

instars.


1 I-11-002

6.2.5 Cyantraniliprole OECD Dossier

IIA Section 4 Residue chemistry. DuPont Y N Y Y Y

201

1

DuPont-

27749

6.2.6 Cyantraniliprole Annex IIIA:

Section 5: Fate in the environment. DuPont N N Y Y Y

201

1

DuPont-

27750

6.1.1 Cyazypyr™ Biological Activity in

Discovery Screens

DuPont,

US N N Y Y Y

201

0

DuPont-

37990

6.1.1.1 Cyazapyr™ translaminar activity

on Myzus persicae on pepper

DuPont

ERDC,

FR

N N Y Y Y 200

8 I-08-001

6.1.1.1

Laboratory characterization of

Cyazapyr™ applied by foliar

application against Bemisia tabaci

on sweet pepper

DuPont

ERDC,

FR

N N Y Y Y 201

0 I-10-013

6.1.2,

6.2.1

The efficacy and crop safety of

DPX-HGW86 10OD on Colorado

Potato Beetle in Potatoes

ATC

Gerhaus Y N Y Y Y

200

9

AST-09-

330

6.1.2,

6.2.1

Insekticide: The efficacy and crop

safety of DPX-HGW86 10OD on

Colorado Potato Beetle in Potatoes

Krasne

Udoli Y N Y Y Y

201

0

CZE-10-

610

6.1.2,

6.2.1




Zkusebni

Stanice

Trutnov.

s.r.o.

Y N Y Y Y 201

0

CZF-10-

610

6.1.2,

6.2.1




Zs

Kujavy Y N Y Y Y

201

0

CZM-10-

610

6.1.2,

6.2.1


DPX-HGW86 10OD and 10SE on


DuPont

DE Y N Y Y Y

200

8

DUH-08-

641

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

6.1.2,

6.2.1




DuPont

DE Y N Y Y Y

200

8

DUL-08-

831

6.1.2,

6.2.1

Efficacy evaluation of insecticides

against the Colorado potato beetle HLB Y N Y Y Y

200

8

BNB-08-

836

6.1.2,

6.1.3,

6.2.1

Efficacy and crop safety of DPX-

E2Y45 20SC and DPX-HGW86

10OD on Colorado Potato Beetle in

Potatoes

Agrostat

Sp. Y N Y Y Y

200

8

PLF-08-

303

6.1.2,

6.1.3,

6.2.1


DPX-HGW86 10OD and DPX-

E2Y 45 20 SC on Colorado Potato

Beetle in Potatoes

Agrostat

Sp. Y N Y Y Y

200

9

PLF-09-

610

6.1.2,

6.1.3,

6.2.1


DPX-HGW86 10OD and DPX-

E2Y 45 20 SC on Colorado Potato

Beetle in Potatoes

Agrostat

Sp. Y N Y Y Y

200

9

PLF-09-

611

6.1.2,

6.1.3,

6.2.1


DPX-HGW86 10OD on Colorado

Potato Beetle in Potatoes

Agrostat

Sp. Y N Y Y Y

201

0

PLF-10-

610

6.1.2,

6.1.3,

6.2.1

The efficacy of DPX-HGW86

10OD on Colorado Potato Beetle in

Potatoes

Agrostat

Sp. Y N Y Y Y

201

1

PLF-11-

610

6.1.3,

6.2.1

Efficacy and crop safety and plant

health of onion after foliar

application of HGW86 10OD to

control Delia antiqua

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

0

BNE-10-

876

6.1.3,

6.2.1





Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

876

6.1.3,

6.2.1





Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

877

6.1.3,

6.2.1


health of onion or leek after foliar



Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

876

6.1.3,

6.2.1





Applied

Plant

Research

Y N Y Y Y 201

0

BNI-10-

877

6.1.2,

6.1.3,

6.2.1





Applied

Plant

Research

Y N Y Y Y 201

0

BNI-10-

878

6.1.3,

6.2.1


health of onion or leek after foliar

Proeftuin

ZwaagdijY N Y Y Y

201

3

BNE-13-

877

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #



k

6.1.2,

6.1.3,

6.2.1


DPX-HGW86 10OD on Thrips

tobaci on onions.

Agrartest Y N Y Y Y 201

1

DUI-11-

849

6.1.2,

6.1.3,

6.2.1


HGW86 10OD on Thrips tabaci on

onions or leeks in the UK, OAT

Oxford

Agricultur

al Trials

Y N Y Y Y 201

0

GBA-10-

663

6.1.2,

6.1.3,

6.2.1

The Efficacy and crop safety of


tabaci on onions. Retford. OAT

Oxford

Agricultur

al Trials

Y N Y Y Y 201

1

GBA-11-

665

6.1.2,

6.1.3,

6.2.1


HGW86 10OD on Thrips tabaci on

onions or leeks in the UK, OAT

Oxford

Agricultur

al Trials

Y N Y Y Y 201

0

GBC-10-

663

6.1.2,

6.1.3,

6.2.1



tabaci on onions.

BIOTEK

Agr. HU Y N Y Y Y

201

1

HUM-11-

805

6.1.2,

6.1.3,

6.2.1



tabaci on onions.

BIOTEK

Agr. HU Y N Y Y Y

201

1

HUM-11-

810

6.1.2,

6.1.3,

6.2.1

Efficacy and crop safety of onion

and leeks after foliar application of

HGW86 10OD to control Thrips

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

664

6.1.2,

6.1.3,

6.2.1


DPX-HGW86 10OD as a foliar

application for the control of Thrips

tabaci in leek.

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

834

6.1.2,

6.1.3,

6.2.1




tabaci in leek.

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

835

6.1.2,

6.1.3,

6.2.1


health of onion and leeks after

foliar application of HGW86 10OD

to control Thrips

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

831

6.1.2,

6.1.3,

6.2.1




tabaci in leek.

Exploras

Agro

Developm

ent

Y N Y Y Y 201

0

BNG-10-

826

6.1.2,

6.1.3,

6.2.1




tabaci in leek.

Exploras

Agro

Developm

ent

Y N Y Y Y 201

0

BNG-10-

827

6.1.2,

6.1.3,

6.2.1




tabaci in leek.

Exploras

Agro

Developm

ent

Y N Y Y Y 201

1

BNG-11-

831

6.1.2,

6.1.3,



Exploras

Agro Y N Y Y Y

201

1

BNG-11-

832

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

6.2.1 application for the control of Thrips

tabaci in leek.

Developm

ent

6.1.2,

6.1.3,

6.2.1




tabaci in leek.

Exploras

Agro

Developm

ent

Y N Y Y Y 201

1

BNG-11-

833

6.1.2,

6.1.3,

6.2.1



tabaci on Leeks.

Oxford

Agricultur

al Trials

Y N Y Y Y 201

1

GBA-11-

666

6.1.2,

6.1.3,

6.2.1

HGW LEEKS – Thrips tabaci.

Coningsby. (Eurofins) Eurofins Y N Y Y Y

201

2

GBA-12-

606

6.1.2,

6.1.3,

6.2.1

Efficacy and crop safety of onion

and leeks after foliar application of

HGW86 10OD to control Thrips

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

663

6.1.3

Evaluation of the performance of

DPX-E2Y45 20SC and DPX-

HGW86 10OD against L.

decemlineata on potato at different

temperatures, vs. other commercial

products

DuPont/E

RDC N N Y Y Y

201

0 I-10-014

6.1.2,

6.1.3,

6.2.1

Rate justification of HGW86

100OD against Psila rosae – Carrot

Fly in Carrot

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

871

6.1.2,

6.1.3,

6.2.1

Rate justification of HGW86

100SE against Psila rosae – Carrot

Fly in Carrot

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

872

6.1.2,

6.1.3,

6.1.4,

6.2.1

Rate justification and interval

comparison of HGW86 100OD

against Psila rosae – Carrot Fly in

Carrot

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

871

6.1.3,

6.1.4,

6.2.1

Efficacy of HGW86 100OD against

Psila rosae – Carrot Fly in Carrot

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

872

6.1.3.

6.1.4,

6.2.1

Efficacy of HGW86 100OD against

Psila rosae – Carrot Fly in Carrot

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

873

6.1.2,

6.1.3,

6.1.4,

6.2.1




Carrot

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

871

6.1.3,

6.1.4,

6.2.1




Carrot

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

874

6.1.2,

6.1.3,

6.1.4,

6.2.1



against carrot fly in carrot.

Landwirts

chaftskam

mer

Nordrhein

Y N Y Y Y 201

1

DUR-11-

320

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

-

Westfalen

Dienststel

le Bonn

6.1.2,

6.1.3,

6.2.1




Carrot

Landwirts

chaftskam

mer

Niedersac

hsen

Pflanzens

chutzamt

Y N Y Y Y 201

2

DUR-12-

382

6.1.2,

6.1.3,

6.2.1




Carrot

Landwirts

chaftskam

mer

Niedersac

hsen

Pflanzens

chutzamt

Y N Y Y Y 201

3

DUR-13-

385

6.1.3,

6.2.1

DPX-E2Y45 35WG, DPX-HGW86

100OD / Carrot / Field efficacy on

Psila rosae

Unilet Y N Y Y Y 200

9

FRG-09-

741

6.1.2,

6.1.3,

6.2.1

Insect: EPPO 14 Psila rosae –

Carrot Fly Crop: Carrot Sileban Y N Y Y Y

200

9

FRG-09-

765

6.1.2,

6.1.3,

6.1.4

Control of carrot fly on carrots with

cyazypyr and rynaxypyr HRI Y N Y Y Y

200

9

GBA-09-

635

6.1.2,

6.1.3,

6.1.4,

6.2.1

Carrot Fly Mortality – Effects of

Aging residues HRI Y N Y Y Y

201

1

GBA-11-

668

6.1.2,

6.1.3,

6.1.4,

6.2.1

Control of Carrot Fly on Carrots.

Wellesbourne. HRI HRI Y N Y Y Y

201

2

GBA-12-

608

6.1.2,

6.1.3,

6.1.4

Control of carrot fly on carrots with

cyazypyr and rynaxypyr HRI Y N Y Y Y

200

9

GBB-09-

635

6.1.2,

6.1.3,

6.1.4,

6.2.1

Carrot Fly Mortality – Effects of

Aging residues HRI Y N Y Y Y

201

1

GBB-11-

668

6.1.2,

6.1.3,

6.1.4,

6.2.1


DPX-HGW86 10OD in control

Psila rosae – Carrot Fly on carrot

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

635

6.1.2,

6.1.3,

6.1.4,


DPX-HGW86 10OD in control

Psila rosae – Carrot Fly on carrot

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

636

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

6.2.1

6.1.2,

6.1.3,

6.2.1

The efficacy of DPX-E2Y45 and

DPX-HGW86 for the control of

Plutella xylostella in cauliflower

De

Bredelaar

B.V.

Y N Y Y Y 200

9

BND-09-

831

6.1.2,

6.1.3,

6.2.1

The efficacy of DPX-E2Y45 and

DPX-HGW86 for the control of

Plutella xylostella in cauliflower

De

Bredelaar

B.V.

Y N Y Y Y 200

9

BND-09-

832

6.1.2,

6.1.3,

6.2.1

The efficacy of DPX-E2Y45

(Coragen) and DPX-HGW86 for

the control of Plutella xylostella in

cauliflower

De

Bredelaar

B.V.

Y N Y Y Y 201

0

BND-10-

831

6.1.2,

6.1.3,

6.2.1




cauliflower

De

Bredelaar

B.V.

Y N Y Y Y 201

0

BND-10-

832

6.1.2,

6.1.3,

6.2.1




cauliflower

De

Bredelaar

B.V.

Y N Y Y Y 201

0

BND-10-

833

6.1.2,

6.1.3,

6.2.1




cauliflower

De

Bredelaar

B.V.

Y N Y Y Y 201

0

BND-10-

834

6.1.3,

6.2.1

Efficacy of foliar appl. HGW86

100 OD and Coragen 20 SC against

Delia brassica in Brussels sprouts

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

823

6.1.3,

6.1.4

Efficacy of foliar appl. HGW86

100 OD and Coragen 20 SC against

Delia brassica in Brussels sprouts

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

824

6.1.3,

6.2.1

Efficacy, crop safety/health of

cabbage after foliar appl. HGW86

10OD or drench appl. HGW86

20SC t control Delia radicum

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

1

BNE-11-

826

6.1.2,

6.1.3,

6.2.1



10OD to control whiteflies

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

821

6.1.2,

6.1.3,

6.2.1




Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

822

6.1.2,

6.1.3,

6.2.1

Efficacy of HGW86 10OD as foliar

application to control Whiteflies in

Brussels sprouts

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

823

6.1.2,

6.1.3,

6.2.1

Efficacy of HGW86 10OD as foliar

application to control Whiteflies in

Brussels sprouts

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

2

BNE-12-

824

6.1.2,

6.1.3,

6.2.1



10OD to control flea beetles

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

818

6.1.2, Efficacy, crop safety/health of Proeftuin Y N Y Y Y 201 BNE-13-

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

6.1.3,

6.2.1


10OD to control flea beetles

Zwaagdij

k

3 819

6.1.2,

6.1.3,

6.2.1



10OD to control Whiteflies

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

821

6.1.2,

6.1.3,

6.2.1




Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

822

6.1.2,

6.1.3,

6.2.1




Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

823

6.1.2,

6.1.3,

6.2.1




Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

824

6.1.2,

6.1.3,

6.2.1




Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

825

6.1.2,

6.1.3,

6.1.4,

6.2.1





Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

826

6.1.2,

6.1.3,

6.1.4,

6.2.1





Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

827

6.1.3,

6.2.1



10OD to control Delia radicum

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

828

6.1.3,

6.1.4,

6.2.1



10OD to control Delia radicum

Proeftuin

Zwaagdij

k

Y N Y Y Y 201

3

BNE-13-

829

6.1.2,

6.1.3,

6.1.4,

6.2.1




Landwirts

chaftskam

mer

Niedersac

hsen

Pflanzens

chutzamt

Y N Y Y Y 201

2

DUR-12-

385

6.1.2,

6.1.3,

6.2.1



10OD to control lepidoptera

Landwirts

chaftskam

mer

Nordrhein

-

Westfalen

Dienststel

le Bonn

Y N Y Y Y 201

2

DUR-12-

386

6.2.1




Landwirts

chaftskam

mer

Y N Y Y Y 201

3

DUR-13-

381

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

Niedersac

hsen

Pflanzens

chutzamt

6.2.1




Landwirts

chaftskam

mer

Nordrhein

-

Westfalen

Dienststel

le Bonn

Y N Y Y Y 201

3

DUR-13-

382

6.1.2.

6.1.3,

6.2.1



10OD to control lepidoptera

Biochem

Agrar

Gmbh

Y N Y Y Y 201

3

DUR-13-

383

6.1.2,

6.1.3,

6.2.1

DPX-HGW86 100OD / Cabbage /

Field efficacy on Lepidoptera

Eurofins

Agroscien

ce

Y N Y Y Y 201

3

FRL-13-

714

6.1.2,

6.1.3,

6.2.1

HGW86 10OD with and without

Codacide on Lepidoptera (Plutella

xylostella, P.brassicae, P.rapae,

M.brassicae) on cabbage

Oat Y N Y Y Y 201

0

GBA-10-

631

6.1.2,

6.1.3

DPX-HGW86 10OD plus Codacide

for whitefly (Aleyrodes proletella)

control on cabbage, cauliflower

Oat Y N Y Y Y 201

0

GBA-10-

632

6.1.2,

6.1.3,

6.1.4,

6.2.1

Evaluation of Cyazypyr for control

of cabbage root fly. HRI

Wellesbourne

HRI Y N Y Y Y 201

2

GBA-12-

603

6.1.2,

6.1.4,

6.2.1

HGW 1 Cabbage - Whitefly. Kirton

Holme. Eurofins Eurofins Y N Y Y Y

201

2

GBA-12-

605

6.1.2,

6.1.3,

6.1.4,

6.2.1

Title: HGW 100OD Brassica :

Whitefly. Whaplode. eurofins Eurofins Y N Y Y Y

201

3

GBA-13-

601

6.1.2,

6.1.3,

6.1.4,

6.2.1

HGW 100OD Brassica: Leps.

Whaplode. Eurofins Eurofins Y N Y Y Y

201

3

GBA-13-

602

6.1.4 HGW 200SC Brassica: Delia

radicum . Little Cherry. HRI HRI Y N Y Y Y

201

3

GBA-13-

603

6.1.2,

6.1.3

DPX-HGW86 10OD plus Codacide

for whitefly (Aleyrodes proletella)

control on cabbage, cauliflower

Oat Y N Y Y Y 201

0

GBB-10-

632

6.1.2,

6.1.3,

6.1.4,

6.2.1

Evaluation of Cyazypyr for control

of cabbage root fly. HRI

Wellesbourne

HRI Y N Y Y Y 201

2

GBB-12-

603

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

6.1.2,6.1

.3, 6.1.4,

6.2.1

HGW 2 Cauliflower - Whitefly.

Kirton Holme. Eurofins Eurofins Y N Y Y Y

201

2

GBB-12-

605

6.1.2,

6.1.3,

6.1.4,

6.2.1

Title: HGW 100OD Brassica:

Whitefly. Melbourne Eurofins Eurofins Y N Y Y Y

201

3

GBB-13-

601

6.1.2,

6.1.3,

6.2.1

HGW 100OD Brassica: Leps.

Kirton Holme. Eurofins Eurofins Y N Y Y Y

201

3

GBB-13-

602

6.1.2,

6.1.3,

6.2.1

HGW86 10OD with and without

Codacide on Lepidoptera (Plutella

xylostella, P.brassicae, P.rapae,

M.brassicae) on cabbage

Oat Y N Y Y Y 201

0

GBC-10-

631

6.1.2,

6.1.3,

6.1.4,

6.2.1

Title: HGW 100OD Brassica:

Whitefly. Fosdyke Eurofins Eurofins Y N Y Y Y

201

3

GBC-13-

601

6.1.2,

6.1.3,

6.1.4,

6.2.1

HGW86 10OD on Lepidoptera

(Plutella xylostella, P.brassicae,

P.rapae, M.brassicae) on cabbage

Biotek

Ag. Y N Y Y Y

201

0

PLE-10-

631

6.1.2,

6.1.3,

6.1.4,

6.2.1

HGW86 10OD on Lepidoptera

(Plutella xylostella, P.brassicae,

P.rapae, M.brassicae) on cabbage

Biotek

Ag. Y N Y Y Y

201

0

PLE-10-

632

6.1.2,

6.1.3,

6.2.1

HGW86 10OD plus Codacide -

Lepidop (P.brassicae, P.rapae,

M.brassicae) on cabbage,

cauliflower

Agrostat

Sp. Y N Y Y Y

201

0

PLF-10-

632

6.1.2,

6.1.3,

6.1.4,

6.2.1

Effectiveness of HGW86 100SC

and HGW86 100OD on Delia

radicum (Root Fly ) on cabbage

Agrostat

Sp. Y N Y Y Y

201

1

PLF-11-

633

6.1.2,

6.1.3,

6.1.4,

6.2.1

Effectiveness of HGW86 100SC

and HGW86 100OD on Delia

radicum (Root Fly ) on cabbage

Agrostat

Sp. Y N Y Y Y

201

1

PLF-11-

634

6.1.3,

6.1.4,

6.2.1




20SC to control Delia radicum

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

630

6.1.3,

6.1.4,

6.2.1





Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

631

6.1.3,

6.1.4,

6.2.1




Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

632

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #


6.1.3,

6.1.4,

6.2.1





Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

633

6.1.3,

6.1.4,

6.2.1





Agrostat

Sp. Y N Y Y Y

201

3

PLF-13-

603

6.1.4,

6.2.1

Registration trial to determine

efficacy and crop safety of HGW86

20SC/10OD on Anthonomus rubi

on strawberry

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

668

6.1.4,

6.2.1




on strawberry

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

669

6.1.4,

6.2.1




on strawberry

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

670

6.1.4,

6.2.1




on strawberry

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

671

6.1.4,

6.2.1




on strawberry

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

672

6.1.4,

6.2.1




on strawberry

Agrostat

Sp. Y N Y Y Y

201

2

PLF-12-

673

6.1.2,

6.1.3,

6.1.4,

6.2.1



10OD/20SC on Anthonomus rubi

on strawberry /raspberry

Agrostat

Sp. Y N Y Y Y

201

3

PLF-13-

623

6.1.2,

6.1.3,

6.1.4,

6.2.1



10OD/20SC on Anthonomus rubi

on strawberry /raspberry

Agrostat

Sp. Y N Y Y Y

201

3

PLF-13-

624

6.1.3,

6.1.4,

6.2.1




on strawberry

Agrostat

Sp. Y N Y Y Y

201

3

PLF-13-

625

6.1.3,

6.1.4,

6.2.1




on strawberry

Agrostat

Sp. Y N Y Y Y

201

3

PLF-13-

626

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

6.1.4.1

Sensory evaluation of tomatoes

treated with DPX-HGW86 10 OD

(a.i. Cyantraniliprole) and DPX-

HGW86 10 OD + Codacide oil.

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

2

S-REP-

125374-1

6.1.4.1

Sensory evaluation of canned

tomatoes treated with DPX-

HGW86-329 (a.i.

Cyantraniliprole).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 200

9

S-REP-

109991-1

6.1.4.1

Sensory evaluation of tomatoes

treated with DPX-HGW86-434 (a.i.

Cyantraniliprole).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

0

S-REP-

114299-1

6.1.4.1

Sensory evaluation of green beans


Cyazapyr(Cyantraniliprole)).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 200

9

S-REP-

109991-3

6.1.4.1

Sensory evaluation of Green Beans


(a.i. Cyantraniliprole).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

2

S-REP-

125208-1

6.1.4.1

Sensory evaluation of potatoes


Cyazapyr).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 200

9

S-REP-

109991-2

6.1.4.1

Sensory Evaluation of Strawberries


(a.i. Cyantraniliprole) with and

without Codacide Oil.

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

4

S-REP-

130044-7

(Strawber

ry_OD)

6.1.4.1

Sensory Evaluation of Carrots

Treated with DPX-HGW86 100

OD (a.i. Cyantraniliprole).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

4

S-REP-

130044-4

(Carrots_

OD)

6.1.4.1

Sensory Evaluation of Cabbage

Treated with DPX-HGW86 100

OD (a.i. Cyantraniliprole) +

Codacide oil.

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

4

S-REP-

130044-3

(Cabbage

_OD)

6.1.4.1

Sensory Evaluation of Carrots

Treated with DPX-HGW86 (a.i.

Cyantraniliprole).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

2

S-REP-

127173-9

6.1.4.1

Sensory Evaluation of Strawberries

Treated with DPX-HGW86 (a.i.

Cyantraniliprole).

CCFRA

Technolo

gy

Limited

Y N Y Y Y 201

2

S-REP-

127173-6

6.2.8

Insecticidal activity of a

developmental compound against

whiteflies.

Rothamst

ed

Research

N N Y Y Y 201

0 I-10-700

6.5.1 HGW86 SE (100g/L) and OD

(100g/L). Their sprayability and

DuPont

ERDC, Y N Y Y Y

200

8

AT-JPH-

08-011

Benevia Part A


15569 N


Point Title

Test

Organisa

tion

GLP

/GE

P

Stud

y

(Y/N

)

Publ

ishe

d

(Y/N

)

Data

prote

ction

claim

ed

(Y/N)

Dat

a

prot

ecti

on

gra

nted

(Y/

N)

Stu

dies

relie

d on

(Y/

N)

Yea

r

DuPont

Report #

robustness to long tank sprayer

time residence

FR

6.5.1

Sprayability evaluation of HGW 86

SE and OD with Codacide in

different water volumes

DuPont

ERDC,

FR

Y N Y Y Y 201

0

AT-JPH-

10-006

6.5.1 Sprayability of HGW 10 OD and

SE in premix with Codacide.

DuPont

ERDC,

FR

Y N Y Y Y 201

0

AT-JPH-

10-016

6.5.3

Evaluation of Rynaxypyr 20SC and

Cyazyrpyr 10OD rain fastness vs.

commercial competitors on patato,

targeting Leptinotarsa decemlineata

neonate larvae.

DuPont/E

RDC N N Y Y Y

200

9 I-09-002

6.2.4

Cyantraniliprole: Non target

arthropod risk assessment for the

EU. Section B6.

DuPont Y N Y Y Y 201

3

DuPont-

35949

6.2.6

Cyantraniliprole (DPX-HGW86)

100 g/L OD: A Greenhouse Study

to Investigate the Effects on

Seedling Emergence and Growth of

Ten Terrestrial Plants Following

Soil Exposure

Wildlife

Internatio

nal Ltd.

MA,

USA.

Y N Y Y Y 200

9

DuPont-

21476

6.2.6


100 g/L OD + Codacide Oil: A

Greenhouse Study to Investigate

the Effects on Seedling Emergence

and Growth of Ten Terrestrial

Plants Following Soil Exposure

Wildlife

Internatio

nal Ltd.

MA,

USA.

Y N Y Y Y 201

0

DuPont-

29049

6.2.7


100 g/L OD: A Greenhouse Study

to Investigate the Effects on

Vegetative Vigor of Ten Terrestrial

Plants Following Foliar Exposure

Wildlife

Internatio

nal Ltd.

MA,

USA.

Y N Y Y Y 200

9

DuPont-

21475

6.2.7

DuPont-17052 – DPX-HGW86:

Laboratory study of vapor pressure

GLP: Yes, Published: No

DuPont

Stine-

Haskell

Research

Center

Y N Y Y Y 200

7

DuPont-

17052

6.2.7


100 glL OD + Codacide Oil: A

Greenhouse Study to Investigate

the Effects on Vegetative Vigor of

Ten Terrestrial Plants Following

Foliar Exposure

Wildlife

Internatio

nal Ltd.

MA,

USA.

Y Y Y Y Y 201

0

DuPont-

29050

Benevia Part A


15569 N


Annex II studies

Annex point


Data pro-tection claimed Y/N

Data pro-tection granted Y/N

Owner

IIA, 1.2/01 2012 Response to PMRA's request for additional chemistry data

for DuPont's cyantraniliprole technical material DuPont-

35884 and DuPont-35884 Confidential attachment GLP: No

Published: No

N N FMC

IIA, 1.8.1/01 2011 Technical grade cyantraniliprole: Product identity and

composition, material use to produce products, production

process and formation of impurities DuPont Stine-Haskell

Research Center DuPont-28593, Revision No. 1 and DuPont-

28593, Revision No. 1, Confidential attachment GLP: No

Published: No

Y Y FMC

IIA, 1.8.1/02 2012 Response to PMRA's request for additional chemistry data



Published: No

N N FMC




Published: No

N N FMC




Published: No

N N FMC

IIA, 1.9.2/01 2011 Cyantraniliprole (DPX-HGW86) certified limits

DuPont Stine-Haskell Research Center DuPont-31311,

Revision No. 1 and DuPont-31311, Revision No. 1,

Confidential attachment GLP: No Published: No

Y Y FMC




Published: No

N N FMC

IIA, 1.11.1/01 2011 Batch analysis of IN-Q6S09 in cyantraniliprole (DPX-

HGW86) technical DuPont Stine-Haskell Research Center,

DuPont Corporate Center for Analytical Sciences, Galbraith

Laboratories, Inc. DuPont-32301 and DuPont-32301,

Confidential attachment GLP: Yes Published: No

Y Y FMC

IIA, 1.11.1/02 2011 Batch chromatograms from the analysis of cyantraniliprole

(DPX-HGW86) technical DuPont Stine-Haskell Research

Center DuPont-27220, Supplement No. 1, Revision No. 1 and

DuPont-27220, Supplement No. 1, Revision No. 1,


Y Y FMC

IIA, 1.11.1/03 2011 Batch analysis of cyantraniliprole (DPX-HGW86) technical

DuPont Stine-Haskell Research Center, DuPont Corporate

Center for Analytical Sciences, Galbraith Laboratories, Inc.

DuPont-27220, Revision No. 1 and DuPont-27220, Revision

No. 1, Confidential attachment GLP: Yes Published: No

Y Y FMC

IIA, 1.11.1/04 2012a Batch analysis of cyantraniliprole (DPX-HGW86) technical

DuPont Stine-Haskell Research Center DuPont-34347 and

DuPont-34347 Confidential attachment GLP: Yes Published:

No

Y Y FMC

IIA, 1.11.1/05 2012b Batch analysis of cyantraniliprole (DPX-HGW86) technical


DuPont-34348 Condfidential attachment GLP: Yes

Published: No

Y Y FMC

IIA, 1.11.1/06 2012c Batch analysis of cyantraniliprole (DPX-HGW86) technical


DuPont-34349 Condfidential attachment GLP: Yes

Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 1.11.1/07 2012d Batch chromatograms from the analysis of cyantraniliprole


Center DuPont-34347, Supplement No. 1 and DuPont-34347,

Supplement No. 1 Confidential attachment GLP: Yes

Published: No

Y Y FMC

IIA, 1.11.1/08 2012e Batch chromatograms from the analysis of cyantraniliprole



Supplement No. 1 Condfidential attachment GLP: Yes

Published: No

Y Y FMC

IIA, 1.11.1/09 2012f Batch chromatograms from the analysis of cyantraniliprole




Published: No

Y Y FMC

IIA, 1.11.2/01 2011a Characterization of cyantraniliprole toxicological sample

DPX-HGW86-141 DuPont Stine-Haskell Research Center,


Laboratories, Inc. DuPont-28165, Revision No. 1 and

DuPont-28165, Revision No. 1, Confidential attachment

GLP: Yes Published: Yes

Y Y FMC

IIA, 1.11.2/02 2011b Characterization of cyantraniliprole toxicological sample






Y Y FMC

IIA, 1.11.2/03 2011c Characterization of cyantraniliprole toxicological sample






Y Y FMC

IIA, 1.11.2/04 2011d Characterization of cyantraniliprole toxicological sample






Y Y FMC

IIA, 1.11.2/05 2011e Characterization of cyantraniliprole toxicological sample






Y Y FMC

IIA,

2.5.2.1/01

2013 Confirmation of identity for determination of impurities in

technical grade cyantraniliprole (DPX-HGW86) DuPont

Stine-Haskell Research Center DuPont-38269, and DuPont-

38269, Confidential attachment GLP: Yes Published: No

Y Y FMC

IIA,

2.5.2.3/01





Y Y FMC

IIA,

2.5.2.4/01





Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 4.2.1/03 2009 Validation of the analytical method for determination of

DPX-HGW86 in technical grade DPX-HGW86 and DPX-

HGW86 end-use products Advinus Therapeutics Private

Limited DuPont-26440, Revision No. 1, and DuPont-26440,

Revision No. 1, Confidential attachment GLP: Yes

Published: No

Y Y FMC

IIA, 4.2.3/01 2011 Description and validation of the analytical methods for

determination of impurities in technical grade

cyantraniliprole (DPX-HGW86) DuPont Stine-Haskell

Research Center; DuPont Experimental Station; Galbraith

Laboratories, Inc. DuPont-28125, Revision No.1 and



Y Y FMC




Published: No

N N FMC

IIA, 1.8.1/01 2011 Technical grade cyantraniliprole: Product identity and

composition, material use to produce products, production

process and formation of impurities DuPont Stine-Haskell

Research Center DuPont-28593 and DuPont-28593

Confidential attachment GLP: No Published No.

N N FMC




Published: No

N N FMC




Published: No

N N FMC




Published: No

N N FMC

IIA, 1.9.2/01 2011 Cyantraniliprole (DPX-HGW86) certified limits DuPont

Stine-Haskell Research Center DuPont-31311, Revision No.

1 and DuPont-31311, Revision No. 1 Confidential attachment

GLP: No Published No.

N N FMC




Published: No

N N FMC

IIA, 1.11.1/01 2011 Batch analysis of IN-Q6S09 in cyantraniliprole (DPX-

HGW86) technical DuPont Stine-Haskell Research Center,


Laboratories, Inc. DuPont-32301 and DuPont-32301


Y Y FMC

IIA, 1.11.1/02 2011 Batch chromatograms from the analysis of cyantraniliprole


Center DuPont-27220, Supplement No. 1, Revision No. 1 and

DuPont-27220, Supplement No. 1, Revision No. 1,


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 1.11.1/03 2011 Batch analysis of cyantraniliprole (DPX-HGW86) technical

DuPont Stine-Haskell Research Center, DuPont Corporate

Center for Analytical Sciences, Galbraith Laboratories, Inc.

DuPont-27220, Revision No.1 and DuPont-27220, Revision

No.1 Confidential attachment GLP: Yes Published: No

Y Y FMC

IIA, 1.11.1/04 2012a Batch analysis of cyantraniliprole (DPX-HGW86) technical



No

Y Y FMC

IIA, 1.11.1/05 2012b Batch analysis of cyantraniliprole (DPX-HGW86) technical



No

Y Y FMC

IIA, 1.11.1/06 2012c Batch analysis of cyantraniliprole (DPX-HGW86) technical



No

Y Y FMC

IIA, 1.11.1/07 2012d Batch chromatograms from the analysis of cyantraniliprole




Published: No

Y Y FMC

IIA, 1.11.1/08 2012e Batch chromatograms from the analysis of cyantraniliprole




Published: No

Y Y FMC

IIA, 1.11.1/09 2012f Batch chromatograms from the analysis of cyantraniliprole




Published: No

Y Y FMC

IIA, 1.11.2/01 2011a Characterization of cyantraniliprole toxicological sample




DuPont-28165, Revision No. 1 Confidential attachment GLP:

Yes Published: No

Y Y FMC

IIA, 1.

11.2/02

2011b Characterization of cyantraniliprole toxicological sample





Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 1.

11.2/03

2011c Characterization of cyantraniliprole toxicological sample





Yes Published: No

Y Y FMC

IIA, 1.11.2/04 2011d Characterization of cyantraniliprole toxicological sample





Yes Published: No

Y Y FMC

IIA, 1.11.2/05 2011e Characterization of cyantraniliprole toxicological sample





Yes Published: No

Y Y FMC

IIA, 1.12/01 2012 Smiles string notation for DPX-HGW86 and its metabolites

DuPont Stine-Haskell Research Center DuPont-35732 GLP:

No Published: No

N N FMC

IIA, 2.1.1/01 2006 DPX-HGW86: Laboratory study of melting, boiling and

decomposition points Covance Laboratories Ltd DuPont-


Y Y FMC

IIA, 2.1.1/02 2009 DPX-HGW86: Laboratory study of physical and chemical

properties of appearance (physical state, colour, odor),

relative density,bulk density melting point and boiling point

IIBAT DuPont-27440 GLP: Yes Published: No

Y Y FMC





Y Y FMC

IIA, 2.1.3/01 2006 DPX-HGW86: Laboratory study of melting, boiling and

decomposition points Covance Laboratories Ltd DuPont-


Y Y FMC

IIA, 2.2/01 2007 DPX-HGW86: Laboratory study of appearance and relative

density/bulk density Charles River Laboratories DuPont-


Y Y FMC

IIA, 2.2/02 2009 DPX-HGW86: Laboratory study of physical and chemical



International Institute of Biotechnology and Toxicology

(IIBAT) DuPont-27440 GLP: Yes Published: No

Y Y FMC

IIA, 2.3.1/01 2007 DPX-HGW86: Laboratory study of vapor pressure DuPont

Stine-Haskell Research Center DuPont-17052 GLP: Yes

Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 2.3.2/01 2007 DPX-HGW85\6: Volatility, calculation of Henry's law

constant DuPont Stine-Haskell Research Center DuPont-


N N FMC

IIA, 2.4.1/01 2007 DPX-HGW86: Laboratory study of appearance and relative



Y Y FMC




IIBAT DuPont-27440 GLP: Yes Published

Y Y FMC

IIA, 2.4.2/01 2007 DPX-HGW86: Laboratory study of appearance and relative



Y Y FMC





Y Y FMC

IIA,

2.5.1.1/01

2007 DPX-HGW86: Laboratory study of UV/visible absorption

and molar absorptivity Charles River Laboratories DuPont-


Y Y FMC

IIA,

2.5.1.2/01

2008 DPX-HGW86: Spectra (mass spectrum, infrared spectrum,

and NMR) ABC Laboratories, Inc. DuPont-17053 GLP: Yes

Published: No

Y Y FMC

IIA,

2.5.1.3/01



Published: No

Y Y FMC

IIA,

2.5.1.4/01



Published: No

Y Y FMC

IIA,

2.5.1.5/01

2007 DPX-HGW86: Laboratory study of UV/visible absorption

and molar absorptivity Charles River Laboratories DuPont-


Y Y FMC

IIA, 2.5.2/01 2013 Confirmation of identity for determination of impurities in




Y Y FMC

IIA, 2.6/01 2007 DPX-HGW86: Laboratory study of water solubility Charles

River Laboratories DuPont-17050 GLP: Yes Published: No

Y Y FMC

IIA, 2.7/01 2009 DPX-HGW86: Laboratory study of solubility in organic

solvents International Institute of Biotechnology and

Toxicology (IIBAT) DuPont-27447 GLP: Yes Published: No

Y Y FMC

IIA, 2.8.1/01 2006 DPX-HGW86: Laboratory study of partition coefficient


Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 2.8.2/01 2006 DPX-HGW86: Laboratory study of partition coefficient


Yes Published: No

Y Y FMC

IIA, 2.9.1/01 2005 Hydrolytic stability of [14C]-DPX-HGW86 in buffered

aqueous solutions at pH 4, 7, and 9 Inveresk DuPont-17058

GLP: Yes Published: N

Y Y FMC

IIA, 2.9.2/01 2007 Photodegradation of [14C]-DPX-HGW86 in pH 4 buffer and

natural water Charles River Laboratories DuPont-17060


Y Y FMC

IIA, 2.9.3/01 2010 Quantum efficiency calculation for IN-RNU71, IN-QKV54

& IN-NXX70 (photolysis metabolites of DPX-HGW86) in

water DuPont Stine-Haskell Research Center DuPont-20286


N N FMC

IIA, 2.9.3/02 2007 Photodegradation of [14C]-DPX-HGW86 in pH 4 buffer and



Y Y FMC

IIA, 2.9.4/01 2008 Calculated theoretical lifetime for DPX-HGW86 in the top

layer of aqueous systems DuPont Stine-Haskell Research

Center DuPont-21506 GLP: No Published: No

N N FMC

IIA, 2.9.5/01 2007 DPX-HGW86: Laboratory study of dissociation constant

Charles River Laboratories DuPont-19176 GLP: Yes

Published: No

Y Y FMC

IIA, 2.10/01 2008 Photochemical oxidative degradation of DPX-HGW86


No Published: No

N N FMC

IIA, 2.11.1/01 2006 DPX-HGW86 technical insecticide: Laboratory study of

explosive properties, flammability of solids, and the relative

self-ignition (autoflammability) temperature DuPont Stine-

Haskell Research Center DuPont-19178 GLP: Yes Published:

No

Y Y FMC

IIA, 2.11.2/01 2006 DPX-HGW86 technical insecticide: Laboratory study of




No

Y Y FMC

IIA, 2.13/01 2006 DPX-HGW86 technical insecticide: Laboratory study of




No

Y Y FMC

IIA, 2.14/01 2009 DPX-HGW86: Laboratory study of surface tension



Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 2.15/01 2008 DPX-HGW86: Laboratory study of oxidising properites

Advinus Therapeutics Private Limited DuPont-26092 GLP:

Yes Published: No

Y Y FMC

IIA, 2.16/01 2007 DPX-HGW86: Laboratory study of pH Charles River

Laboratories DuPont-19177 GLP: Yes Published: No

Y Y FMC

IIA, 2.16/02 2012 Cyantraniliprole (DPX-HGW86): Determination of pH ABC

Laboratories, Inc. (Missouri) DuPont-35171 GLP: Yes

Published No

Y Y FMC

IIA, 2.17.1/01 2010 DPX-HGW86: Laboratory study of storage stability and

corrosion characteristics International Institute of

Biotechnology and Toxicology (IIBAT) DuPont-28001 GLP:

Yes Published: No

Y Y FMC

IIA, 2.17.2/01 2009 DPX-HGW86: Stability to normal and elevated temperature,

metals and metal ions International Institute of Biotechnology

and Toxicology (IIBAT) DuPont-27973 GLP: Yes Published:

No

Y Y FMC

IIA, 2.18/01 2007 Laboratory determination of the n-octanol/water partition

coefficients of DPX-HGW86 metabolites: Estimation by

HPLC DuPont Stine-Haskell Research Center DuPont-20591


Y Y FMC

IIA, 2.18/02 2010a IN-RNU71, IN-QKV54 and IN-NXX70 (photolysis products

of DPX-HGW86): Laboratory determination of the n-

octanol/water partition International Institute of


Yes Published: No

Y Y FMC

IIA, 2.18/03 2010b IN-RNU71, IN-QKV54, and IN-NXX70 (photolysis products

of DPX-HGW86): UV/visible absorption spectrum and molar

absorptivity International Institute of Biotechnology and


Y Y FMC

IIA, 9.0/01 2012 Classification of cyantraniliprole (DPX-HGW86) technical


No Published: No

N N FMC

IIA, 4.2.1/01 2011 Determination of cyantraniliprole (DPX-HGW86) in

technical grade cyantraniliprole and DPX-HGW86 end-use

products DuPont Stine-Haskell Research Center DuPont-


N N FMC

IIA, 4.2.1/02 2011 Validation of the analytical method for the determination of

cyantraniliprole (DPX-HGW86) in technical grade

cyantraniliprole and DPX-HGW86 end-use products DuPont


Published:

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 4.2.1/03 2009 Validation of the analytical method for determination of

DPX-HGW86 in technical grade DPX-HGW86 and DPX-

HGW86 end-use products (confidential attachment) Advinus

Therapeutics Private Limited DuPont-26440, Revision No. 1,

and DuPont-26440, Revision No. 1 Confidential attachment


Y Y FMC

IIA, 4.2.3/01 2011 Description and validation of the analytical methods for

determination of impurities in technical grade

cyantraniliprole (DPX-HGW86) DuPont Stine-Haskell

Research Center; DuPont Experimental Station; Galbraith



Yes Published: No

N N FMC

IIA, 4.3/01 2009 Method assessment and validation for the determination of

residues of DPX-HGW86 in plants using multi-residue

method DFG S19 (LC-MS/MS module) PTRL Europe


Y Y FMC

IIA, 4.3/02 2010 Method assessment and validation for the determination of

residues of DPX-HGW86 and metabolites in animal tissues

using multi-residue method DFG S19 (LC/MS/MS module)

PTRL Europe DuPont-25544 GLP: Yes Published: No

Y Y FMC

IIA, 4.3/03 2010 Analytical method for the determination of DPX-HGW86

and metabolites in bovine tissues, dairy, and eggs using

LC/MS/MS DuPont Stine-Haskell Research Center DuPont-


N N FMC

IIA, 4.3/04 2008 Method validation for the analysis of DPX-HGW86 and its

metabolites (IN-N7B69, IN-JCZ38, IN-K7H19, IN-MYX98,

IN-MLA84 and IN-J9Z38) in various crops with LC-MS/MS

detection Charles River Laboratories DuPont-18846 GLP:

Yes Published: No

Y Y FMC

IIA, 4.3/05 2010 Extraction efficiency of [14C]DPX-HGW86 from muscle,

liver and milk from goats and eggs from hens Charles River


Y Y FMC

IIA, 4.3/06 2009 Extraction efficiency of [14C]DPX-HGW86 from crops


Published: No

Y Y FMC


and metabolites in processed fractions using LC/MS/MS

ABC Laboratories, Inc. DuPont-15736, Supplement No. 1


N N FMC


and metabolites in crops using LC/MS/MS DuPont Stine-

Haskell Research Center DuPont-15736, Revision No. 1


N N FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 4.3/09 2009 Multiresidue method testing for DPX-HGW86 and six

metabolites according to the FDA pesticide analytical manual

volume I (PAM, Vol. I as revised in October 1999),

Appendix II Pyxant Labs, Inc. DuPont-21329 GLP: Yes

Published: No

Y Y FMC

IIA, 4.3/10 2010 Independent laboratory validation of DuPont-18844 method

for the determination of residues of DPX-HGW86 and

metabolites in milk and bovine tissues using LC/MS/MS

PTRL Europe DuPont-26458 GLP: Yes Published: No

Y Y FMC

IIA, 4.3/11 2010 Independent laboratory validation of "Analytical method for

the determination of DPX-HGW86 and metabolites in crops

and processed fractions using LC/MS/MS" Pyxant Labs, Inc.


Y Y FMC

IIA, 4.3/12 2010 Validation of an analytical method for the determination of

DPX-HGW86, IN-HGW87, IN-N7B69, IN-K7H19, IN-

JCZ38, IN-MYX98, IN-J9Z38 and IN-MLA84 in bovine

tissues, milk and eggs Charles River Laboratories DuPont-


Y Y FMC

IIA, 4.3/13 2010a Independent laboratory validation for the determination of

residues of DPX-HGW86 in plants using multi-residue

method DFG S 19 (LC-MS/MS module) Eurofins Dr. Specht

GLP GmbH DuPont-21326 GLP: Yes Published: No

Y Y FMC

IIA, 4.3/14 2010b Independent laboratory validation for the determination of

residues of DPX-HGW86 in animal tissues using multi-

residue method DFG S 19 (LC-MS/MS module) Eurofins Dr.

Specht GLP GmbH DuPont-17942 GLP: Yes Published: No

Y Y FMC


and metabolites in soil using LC/MS/MS DuPont Stine-

Haskell Research Center DuPont-15440 GLP: No Published:

No

N N FMC

IIA, 4.4/02 2010 Extraction efficiency of DPX-HGW86 from soil DuPont


Published: No

Y Y FMC

IIA, 4.4/03 2010 Independent laboratory validation of DuPont-15440 method

for the determination of residues of DPX-HGW86 and

metabolites in soil using LC/MS/MS PTRL Europe DuPont-


Y Y FMC

IIA, 4.4/04 2010 Independent laboratory validation of "Analytical method for

the determination of DPX-HGW86 and photoproducts in soil

using LC/MS/MS" ABC Laboratories, Inc. DuPont-30770


Y Y FMC


and photoproducts in soil using LC/MS/MS ABC

Laboratories, Inc. DuPont-29747 GLP: No Published: No

N N FMC

Benevia Part A


15569 N


Annex point




Owner

IIA 4.4/06 2012 Response to PMRA's request for additional chemistry data



Published: No

N N FMC


and metabolites in water (pond, stream, well, and tap) using

LC/MS/MS ABC Laboratories, Inc. DuPont-18850 GLP: No

Published: No

N N FMC

IIA, 4.5/02 2010 Independent laboratory validation of an analytical method for

the determination of DPX-HGW86 and metabolites in water

(surface, ground and tap) using LC-MS/MS Eurofins Dr.

Specht GLP GmbH DuPont-27357 GLP: Yes Published: No

Y Y FMC




Published: No

N N FMC

IIA, 4.6/01 2010 Sediment method validation (non-GLP) for HGW86 and

metabolites ABC Laboratories, Inc. DuPont-18848 GLP: No

Published: No

Y Y FMC




Published: No

N N FMC

IIA, 4.7/01 2009 Analytical method for the determination of DPX-HGW86 in

air using LC/MS/MS PTRL Europe DuPont-21330 GLP: Yes

Published: No

Y Y FMC




Published: No

N N FMC

IIA, 4.9/01 2010 Validation of an analytical method for the determination of

DPX-HGW86 and metabolites in bee products Charles River


Y Y FMC

IIA, 4.9/02 2010 Dissipation of dislodgeable foliar residues of DPX-HGW86

following foliar application of DPX-HGW86 SE (100 g ai/L)

to apple trees ABC Laboratories, Inc. DuPont-27935 GLP:

Yes Published: No

Y Y FMC

IIA, 5.1.1/01 2010 14C-DPX-HGW86: Absorption, distribution, metabolism and

excretion in male and female rats DuPont Haskell

Laboratories DuPont-16995, Revision No. 1 GLP: Yes

Published: No

Y Y FMC

IIA, 5.1.3/01 2010 14C-DPX-HGW86: Disposition in male and female rats

during and after multiple dose administration DuPont Haskell


Published: No

Y Y FMC

IIA, 5.2.1/01 2008a DPX-HGW86 technical: Acute oral toxicity study in mice -

up-and-down procedure DuPont Haskell Laboratories


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 5.2.1/02 2008b DPX-HGW86 Technical: Acute oral toxicity study in rats -



Y Y FMC

IIA, 5.2.1/03 2009a Cyantraniliprole (DPX-HGW86) technical: Acute oral

toxicity study in rats - up-and-down procedure DuPont

Haskell Laboratories DuPont-27896 GLP: Yes Published: No

Y Y FMC

IIA, 5.2.1/04 2009b Cyantraniliprole (DPX-HGW86) technical: Acute oral



Y Y FMC

IIA, 5.2.1/05 2010 Cyantraniliprole (DPX-HGW86) technical: Acute oral

toxicity = Up-and-down procedure in rats Eurofins PSL


Y Y FMC

IIA, 5.2.2/01 2008 DPX-HGW86 technical: Acute dermal toxicity study in rats

DuPont Haskell Laboratories DuPont-18966 GLP: Yes

Published: No

Y Y FMC

IIA, 5.2.3/01 2009 Acute inhalation toxicity study of DPX-HGW86 technical in

albino rats WIL Research Laboratories, LLC DuPont-18971


Y Y FMC

IIA, 5.2.4/01 2008 DPX-HGW86 technical: Acute dermal irritation study in

rabbits DuPont Haskell Laboratories DuPont-18967 GLP:

Yes Published: No

Y Y FMC

IIA, 5.2.4/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute dermal

irritation study in rabbits DuPont Haskell Laboratories


Y Y FMC

IIA, 5.2.4/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute dermal



Y Y FMC

IIA, 5.2.4/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary skin

irritation in rabbits Eurofins PSL DuPont-30995 GLP: Yes

Published: No

Y Y FMC

IIA, 5.2.5/01 2008 DPX-HGW86 technical: Acute eye irritation study in rabbits


Published: No

Y Y FMC

IIA, 5.2.5/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute eye



Y Y FMC

IIA, 5.2.5/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute eye



Y Y FMC

IIA, 5.2.5/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary eye


Published: No

Y Y FMC

IIA, 5.2.6/01 2011 Cyantraniliprole (DPX-HGW86) technical: Local lymph

node assay (LLNA) in mice DuPont Haskell Laboratories

DuPont-27560, Revision No.1 GLP: Yes Published: No

Y Y FMC

IIA, 5.2.6/02 2011 Cyantraniliprole (DPX-HGW86) technical: Dermal

sensitisation - Buehler method Eurofins PSL DuPont-30418,

Revision No. 1 GLP: Yes Published: No

Y Y FMC

IIA, 5.2.6/03 2007 DPX-HGW86: Local lymph node assay (LLNA) in mice


Published: No

Y Y FMC




Y Y FMC

IIA, 5.2.6/05 2011 A skin sensitisation study of DPX-HGW86 technical in

guinea pigs (maximization test) Kannami Laboratory, Bozo

Research Center Inc. DuPont-30996, Revision No. 1 GLP:

Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner


sensitisation - Magnusson-Kligman maximization method

Eurofins, Product Safety Laboratories DuPont-29062 GLP:

Yes Published: No

Y Y FMC

IIA, 5.3.1/01 2009a DPX-HGW86 technical: Repeated dose oral toxicity 28-day

feeding study in rats DuPont Haskell Laboratories DuPont-


N N FMC

IIA, 5.3.1/02 2009b DPX-HGW86 technical: Repeated dose oral toxicity 28-day

feeding study in mice DuPont Haskell Laboratories DuPont-


N N FMC

IIA, 5.3.1/03 2007 DPX-HGW86: 28-day oral palatability study in dogs MPI

Research DuPont-15456 GLP: No Published: No

N N FMC

IIA, 5.3.1/04 2010 Cyantraniliprole (DPX-HGW86) technical: Repeated-dose

oral toxicity 2-week gavage study in rats with metabolism

and genetic toxicology DuPont Haskell Laboratories,

Experimental Pathology Laboratories, Inc. DuPont-13430,

Revision No. 1 GLP: No Published: No

N N FMC

IIA, 5.3.2/01 2007 DPX-HGW86 technical: Subchronic toxicity 90-day feeding

study in rats DuPont Haskell Laboratories DuPont-16993


Y Y FMC

IIA, 5.3.2/02 2011a DPX-HGW86 technical: Subchronic toxicity 90-day feeding

study in mice DuPont Haskell Laboratories DuPont-16992,

Supplement No. 1, Revision No. 1 GLP: Yes Published: No

Y Y FMC

IIA, 5.3.2/03 2011b DPX-HGW86 technical: Subchronic toxicity 90-day feeding

study in rats DuPont Haskell Laboratories DuPont-16993,


Y Y FMC


study in mice DuPont Haskell Laboratories, Experimental

Pathology Laboratories, Inc. DuPont-16992 GLP: Yes

Published: No

Y Y FMC

IIA, 5.3.3/01 2009 DPX-HGW86 Technical: 90-day dietary toxicity study in

dogs MPI Research DuPont-16994, Supplement No. 1,


Y Y FMC

IIA, 5.3.3/02 2007 DPX-HGW86 technical: 90-day dietary toxicity study in

dogs MPI Research DuPont-16994, Revision No. 1 GLP: Yes

Published: No

Y Y FMC

IIA, 5.3.4/01 2010 DPX-HGW86 technical: Chronic toxicity 1-year feeding

study in dogs MPI Research, Inc. DuPont-19180 GLP: Yes

Published: No

Y Y FMC


study in dogs DuPont Haskell Laboratories; MPI Research,

Inc. DuPont-19180, Supplement No. 1 GLP: Yes Published:

No

Y Y FMC

IIA, 5.3.5/01 2012 Cyantraniliprole: Additional information in support of

DuPont-32967, four-week inhalation toxicity study in rats


Yes Published: No

Y Y FMC

IIA, 5.3.5/02 2012 Cyantraniliprole (DPX-HGW86) technical: Four-week

inhalation toxicity study in rats

DuPont Haskell Laboratories DuPont-32967, Revision No. 1


Y Y FMC

IIA, 5.3.7/01 2009 Cyantraniliprole (DPX-HGW86) technical: 28 day repeat

dermal application study in rats Eurofins, Product Safety

Laboratories DuPont-21316, Revision No.1 GLP: Yes

Published: No

Y Y FMC

IIA, 5.4.1/01 2010 Cyantraniliprole (DPX-HGW86) technical: Bacterial reverse

mutation assay BioReliance DuPont-30991 GLP: Yes

Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 5.4.1/02 2009a Cyantraniliprole (DPX-HGW86): Bacterial reverse mutation

assay BioReliance DuPont-27160 GLP: Yes Published: No

Y Y FMC

IIA, 5.4.1/03 2009b Cyantraniliprole (DPX-HGW86) technical: Bacterial reverse

mutation assay BioReliance DuPont-27900 GLP: No

Published: No

N N FMC

IIA, 5.4.2/01 2009a Cyantraniliprole (DPX-HGW86) technical: In vitro

mammalian chromosome aberration test BioReliance


Y Y FMC

IIA, 5.4.2/02 2009b Cyantraniliprole (DPX-HGW86) technical: In vitro



Y Y FMC

IIA, 5.4.2/03 2010 Cyantraniliprole (DPX-HGW86) technical: In vitro


DuPont-30990 GLP: No Published: No

N N FMC

IIA, 5.4.3/01 2010 Cyantraniliprole (DPX-HGW86) technical: In vitro

mammalian cell gene mutation test (CHO/HGPRT) assay

BioReliance DuPont-30992 GLP: Yes Published: No

Y Y FMC

IIA, 5.4.3/02 2011 Cyantraniliprole (DPX-HGW86) technical: CHO/HPRT

forward mutation assay with duplicate cultures Covance

Laboratories, Inc. DuPont-31372 GLP: Yes Published: No

Y Y FMC

IIA, 5.4.4/01 2011 Cyantraniliprole (DPX-HGW86) technical: Mouse bone

marrow micronucleus test DuPont Haskell Laboratories


Y Y FMC

IIA, 5.5.1/01 2011 Cyantraniliprole technical (DPX-HGW86 commercial batch -

412): Combined chronic toxicity/oncogenicity study 2-year

feeding study in rats MPI Research, Inc. DuPont-26842 GLP:

Yes Published: No

Y Y FMC

IIA, 5.5.1/02 2013 Cyantraniliprole: Response to toxicology questions

(December 12, 2011) DuPont Stine-Haskell DuPont-34740,


Y Y FMC




Yes Published: No

Y Y FMC

IIA, 5.5.3/01 2011 Cyantraniliprole (DPX-HGW86) technical: Oncogenicity

study 18-month feeding study in mice MPI Research, Inc.


Y Y FMC

IIA, 5.6.1/01 2011 DPX-HGW86 technical: Oral (diet) two-generation (one litter

per generation) reproduction toxicity study in rats Charles

River Laboratories, DuPont-19187 GLP: Yes Published: No

Y Y FMC

IIA, 5.6.10/01 2009 DPX-HGW86 technical: Developmental toxicity in rats


Published: No

Y Y FMC

IIA, 5.6.11/01 2009 DPX-HGW86 technical: Developmental toxicity study in


Yes Published: No

Y Y FMC

IIA, 5.7.1/01 2006 DPX-HGW86 technical: Acute oral neurotoxicity study in

rats DuPont Haskell Laboratories DuPont-16996 GLP: Yes

Published: No

Y Y FMC

IIA, 5.7.4/01 2009 DPX-HGW86 technical: Subchronic oral neurotoxicity study

in rats DuPont Haskell Laboratories DuPont-19186 GLP: Yes

Published: No

Y Y FMC

IIA, 5.8.01 2010 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study


Published: No

Y Y FMC

IIA, 5.8.02 2010a IN-PLT97: Acute oral toxicity study in mice - up-and-down

procedure DuPont Haskell Laboratories DuPont-30571 GLP:

Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 5.8/03 2010b IN-N5M09: Acute oral toxicity study in mice - up-and-down


Yes Published: No

Y Y FMC

IIA, 5.8/04 2009 IN-JSE76: In vitro mammalian cell gene mutation test

(CHO/HGPRT Assay) BioReliance DuPont-24714 GLP: Yes

Published: No

Y Y FMC

IIA, 5.8/05 2010 IN-PLT97: In vitro mammalian cell gene mutation test


Published: No

Y Y FMC

IIA, 5.8/06 2006 IN-F6L99: Acute oral toxicity study in mice - up-and-down


Yes Published: No

Y Y FMC

IIA, 5.8/07 2010 IN-JSE76: In vitro mammalian chromosome aberration test

BioReliance DuPont-24715, Revision No. 2 GLP: Yes

Published: No

Y Y FMC

IIA, 5.8/08 2011 IN-PLT97: In vitro mammalian chromosome aberration test


Published: No

Y Y FMC

IIA, 5.8/09 2011 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study

in rats DuPont Haskell Laboratories DuPont-28842,

Supplement No. 1 GLP: Yes Published: No

Y Y FMC

IIA, 5.8/10 2006 IN-F6L99: Bacterial reverse mutation test DuPont Haskell


Y Y FMC

IIA, 5.8/11 2009 IN-JSE76: Acute oral toxicity - up-and-down procedure in

rats Eurofins, Product Safety Laboratories DuPont-26932,

Revision No.1 GLP: Yes Published: No

Y Y FMC

IIA, 5.8/12 2010 IN-PLT97: Bacterial reverse mutation assay BioReliance

DuPont-30552 Revision No.1 GLP: Yes Published: No

Y Y FMC

IIA, 5.8/13 2009a IN-JSE76: Bacterial reverse mutation assay BioReliance


Y Y FMC

IIA, 5.8/14 2009b IN-N5M09: Bacterial reverse mutation assay BioReliance


Y Y FMC

IIA, 5.8/15 2013 Cyantraniliprole: Toxicological assessment of the metabolite,

IN-M2G98 DuPont-37346, Revision No. 1 DuPont Stine-

Haskell Research Center GLP: No Published: No

N N FMC

IIA, 5.8/16 2006 IN-DBC80: Acute oral toxicity study in rats - up-and-down

procedure DuPont Haskell Laboratory for Health and

Environmental Sciences DuPont-17907 GLP: Yes Published:

No

Y Y FMC

IIA, 5.8/17 2006 IN-DBC80: Bacterial reverse mutation test DuPont Haskell

Laboratory for Health and Environmental Sciences DuPont-


Y Y FMC

IIA, 5.8/18 2007 IN-DBC80: In vitro mammalian chromosome aberration test

in human peripheral blood lymphocytes DuPont Haskell

Laboratory for Health and Environmental Sciences DuPont-


Y Y FMC

IIA, 5.8/19 2006 IN-DBC80: Local lymph node assay (LLNA) in mice DuPont

Haskell Laboratory for Health and Environmental Sciences


Y Y FMC

IIA, 5.8/20 2006 IN-DBC80: Inhalation median lethal concentration (LC50)

study in rats DuPont Haskell Laboratory for Health and


No

Y Y FMC

IIA, 5.10/01 2009 Cyantraniliprole (DPX-HGW86) technical: 28-day

immunotoxicity feeding study in rats DuPont Haskell


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner


immunotoxicity feeding study in mice DuPont Haskell


Published: No

Y Y FMC

IIA, 5.10/03 2010a Cyantraniliprole (DPX-HGW86) technical: Adrenal and

thyroid mechanistic: 90-day feeding study in rats DuPont

Haskell Laboratories; Experimental Pathology Laboratories,

Inc.; Laboratory for Advanced Electron and Light Optical

Methods (LAELOM) DuPont-24319 GLP: Yes Published:

No

Y Y FMC

IIA, 5.10/04 2010b Cyantraniliprole (DPX-HGW86) technical: Adrenal

mechanistic study 90-day feeding study in mice DuPont




No

Y Y FMC

IIA, 5.10/05 2010 Cyantraniliprole (DPX-HGW86) technical: In vitro thyroid

peroxidase inhibition Dupont Haskell Laboratories DuPont-


N N FMC

IIA, 5.8/21 2013 IN-M2G98: In vitro mammalian cell gene mutation test

(CHO/HGPRT assay) BioReliance, Alliance Pharma, Inc.


Y Y FMC

IIA, 5.8/22 2013 IN-M2G98: In vitro mammalian chromosome aberration test


Global Centers for Health & Environmental Sciences,

Alliance Pharma, Inc. DuPont-37573 GLP: Yes Published:

No

Y Y FMC

IIA, 5.8/23 2013 IN-M2G98: Bacterial reverse mutation test BioReliance


Y Y FMC

IIA, 5.8/24 2012 IN-PLT97: Repeated-dose oral toxicity 28-day feeding study

in rats DuPont Haskell Global Centers for Health &


No

Y Y FMC



Environmental Sciences DuPont-33376, Supplement No. 1


Y Y FMC

IIA, 5.11/01 2014 Cyantraniliprole toxicological assessment of ground water

metabolites in the context of EU Council Directive

91/414/EEC (SANCO/221/2000 – REV. 10, March 2003)

DuPont Stine-Haskell Laboratories DuPont-35730 GLP: No

Published: No

N N FMC

IIA, 5.1.1/01 2010 14C-DPX-HGW86: Absorption, distribution, metabolism and

excretion in male and female rats DuPont Haskell


Published: No

Y Y FMC

IIA, 5.1.3/01 2010 14C-DPX-HGW86: Disposition in male and female rats

during and after multiple dose administration DuPont Haskell


Published: No

Y Y FMC

IIA, 5.2.1/01 2008a DPX-HGW86 technical: Acute oral toxicity study in mice -



Y Y FMC

IIA, 5.2.1/02 2008b DPX-HGW86 technical: Acute oral toxicity study in rats -



Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 5.2.1/03 2009a Cyantraniliprole (DPX-HGW86) technical: Acute oral



Y Y FMC

IIA, 5.2.1/04 2009b Cyantraniliprole (DPX-HGW86) technical: Acute oral



Y Y FMC

IIA, 5.2.1/05 2010 Cyantraniliprole (DPX-HGW86) technical: Acute oral

toxicity = Up-and-down procedure in rats Eurofins PSL


Y Y FMC

IIA, 5.2.2/01 2008 DPX-HGW86 technical: Acute dermal toxicity study in rats


Published: No

Y Y FMC

IIA, 5.2.3/01 2009 Acute inhalation toxicity study of DPX-HGW86 technical in

albino rats WIL Research Laboratories, LLC DuPont-18971


Y Y FMC

IIA, 5.2.4/01 2008 DPX-HGW86 technical: Acute dermal irritation study in


Yes Published: No

Y Y FMC

IIA, 5.2.4/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute dermal



Y Y FMC

IIA, 5.2.4/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute dermal



Y Y FMC

IIA, 5.2.4/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary skin


Published: No

Y Y FMC

IIA, 5.2.5/01 2008 DPX-HGW86 technical: Acute eye irritation study in rabbits


Published: No

Y Y FMC

IIA, 5.2.5/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute eye



Y Y FMC

IIA, 5.2.5/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute eye



Y Y FMC

IIA, 5.2.5/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary eye


Published: No

Y Y FMC



DuPont-27560, Revision No.1 GLP: Yes Published: No

Y Y FMC


sensitisation - Buehler method Eurofins PSL DuPont-30418,


Y Y FMC

IIA, 5.2.6/03 2007 DPX-HGW86: Local lymph node assay (LLNA) in mice


Published: No

Y Y FMC




Y Y FMC

IIA, 5.2.6/05 2011 A skin sensitisation study of DPX-HGW86 technical in

guinea pigs (maximization test) Kannami Laboratory, Bozo

Research Center Inc. DuPont-30996, Revision No. 1 GLP:

Yes Published: No

Y Y FMC


sensitisation - Magnusson-Kligman maximization method

Eurofins, Product Safety Laboratories DuPont-29062 GLP:

Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 5.3.1/01 2009a DPX-HGW86 technical: Repeated dose oral toxicity 28-day

feeding study in rats DuPont Haskell Laboratories DuPont-


N N FMC

IIA, 5.3.1/02 2009b DPX-HGW86 technical: Repeated dose oral toxicity 28-day

feeding study in mice DuPont Haskell Laboratories DuPont-


N N FMC

IIA, 5.3.1/03 2007 DPX-HGW86: 28-day oral palatability study in dogs MPI

Research DuPont-15456 GLP: No Published: No

N N FMC

IIA, 5.3.1/04 2010 Cyantraniliprole (DPX-HGW86) technical: Repeated-dose

oral toxicity 2-week gavage study in rats with metabolism

and genetic toxicology DuPont Haskell Laboratories,

Experimental Pathology Laboratories, Inc. DuPont-13430,


N N FMC


study in rats DuPont Haskell Laboratories DuPont-16993


Y Y FMC

IIA, 5.3.2/02 2011a DPX-HGW86 technical: Subchronic toxicity 90-day feeding

study in mice DuPont Haskell Laboratories DuPont-16992,


Y Y FMC

IIA, 5.3.2/03 2011b DPX-HGW86 technical: Subchronic toxicity 90-day feeding

study in rats DuPont Haskell Laboratories DuPont-16993,


Y Y FMC


study in mice DuPont Haskell Laboratories, Experimental

Pathology Laboratories, Inc. DuPont-16992 GLP: Yes

Published: No

Y Y FMC

IIA, 5.3.3/01 2009 DPX-HGW86 Technical: 90-day dietary toxicity study in

dogs MPI Research DuPont-16994, Supplement No. 1,


Y Y FMC

IIA, 5.3.3/02 2007 DPX-HGW86 technical: 90-day dietary toxicity study in

dogs MPI Research DuPont-16994, Revision No. 1 GLP: Yes

Published: No

Y Y FMC


study in dogs MPI Research, Inc. DuPont-19180 GLP: Yes

Published: No

Y Y FMC


study in dogs DuPont Haskell Laboratories; MPI Research,

Inc. DuPont-19180, Supplement No. 1 GLP: Yes Published:

No

Y Y FMC

IIA, 5.3.5/01 2012 Cyantraniliprole: Additional information in support of

DuPont-32967, four-week inhalation toxicity study in rats


Yes Published: No

Y Y FMC

IIA, 5.3.5/02 2012 Cyantraniliprole (DPX-HGW86) technical: Four-week

inhalation toxicity study in rats

DuPont Haskell Laboratories DuPont-32967, Revision No. 1


Y Y FMC

IIA, 5.3.7/01 2009 Cyantraniliprole (DPX-HGW86) technical: 28 day repeat

dermal application study in rats Eurofins, Product Safety

Laboratories DuPont-21316, Revision No.1 GLP: Yes

Published: No

Y Y FMC




Yes Published: No

Y Y FMC




Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 5.5.3/01 2011 Cyantraniliprole (DPX-HGW86) technical: Oncogenicity

study 18-month feeding study in mice MPI Research, Inc.


Y Y FMC

IIA, 5.6.1/01 2011 DPX-HGW86 technical: Oral (diet) two-generation (one litter

per generation) reproduction toxicity study in rats Charles

River Laboratories, DuPont-19187 GLP: Yes Published: No

Y Y FMC

IIA, 5.6.10/01 2009 DPX-HGW86 technical: Developmental toxicity in rats


Published: No

Y Y FMC

IIA, 5.6.11/01 2009 DPX-HGW86 technical: Developmental toxicity study in


Yes Published: No

Y Y FMC

IIA, 5.7.1/01 2006 DPX-HGW86 technical: Acute oral neurotoxicity study in

rats DuPont Haskell Laboratories DuPont-16996 GLP: Yes

Published: No

Y Y FMC

IIA, 5.7.4/01 2009 DPX-HGW86 technical: Subchronic oral neurotoxicity study


Published: No

Y Y FMC

IIA, 5.8.01 2010 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study


Published: No

Y Y FMC

IIA, 5.8.02 2010a IN-PLT97: Acute oral toxicity study in mice - up-and-down


Yes Published: No

Y Y FMC

IIA, 5.8/03 2010b IN-N5M09: Acute oral toxicity study in mice - up-and-down


Yes Published: No

Y Y FMC

IIA, 5.8/04 2009 IN-JSE76: In vitro mammalian cell gene mutation test


Published: No

Y Y FMC

IIA, 5.8/05 2010 IN-PLT97: In vitro mammalian cell gene mutation test


Published: No

Y Y FMC

IIA, 5.8/06 2006 IN-F6L99: Acute oral toxicity study in mice - up-and-down


Yes Published: No

Y Y FMC

IIA, 5.8/07 2010 IN-JSE76: In vitro mammalian chromosome aberration test


Published: No

Y Y FMC

IIA, 5.8/08 2011 IN-PLT97: In vitro mammalian chromosome aberration test


Published: No

Y Y FMC

IIA, 5.8/09 2011 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study

in rats DuPont Haskell Laboratories DuPont-28842,

Supplement No. 1 GLP: Yes Published: No

Y Y FMC

IIA, 5.8/10 2006 IN-F6L99: Bacterial reverse mutation test DuPont Haskell


Y Y FMC

IIA, 5.8/11 2009 IN-JSE76: Acute oral toxicity - up-and-down procedure in

rats Eurofins, Product Safety Laboratories DuPont-26932,

Revision No.1 GLP: Yes Published: No

Y Y FMC

IIA, 5.8/12 2010 IN-PLT97: Bacterial reverse mutation assay BioReliance

DuPont-30552 Revision No.1 GLP: Yes Published: No

Y Y FMC

IIA, 5.8/13 2009a IN-JSE76: Bacterial reverse mutation assay BioReliance


Y Y FMC

IIA, 5.8/14 2009b IN-N5M09: Bacterial reverse mutation assay BioReliance


Y Y FMC

IIA, 5.8/15 2013 Cyantraniliprole: Toxicological assessment of the metabolite,

IN-M2G98 DuPont-37346, Revision No. 1 DuPont Stine-

Haskell Research Center GLP: No Published: No

N N FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 5.8/16 2006 IN-DBC80: Acute oral toxicity study in rats - up-and-down

procedure DuPont Haskell Laboratory for Health and


No

Y Y FMC

IIA, 5.8/19 2006 IN-DBC80: Local lymph node assay (LLNA) in mice DuPont

Haskell Laboratory for Health and Environmental Sciences


Y Y FMC

IIA, 5.8/20 2006 IN-DBC80: Inhalation median lethal concentration (LC50)

study in rats DuPont Haskell Laboratory for Health and


No

Y Y FMC


immunotoxicity feeding study in rats DuPont Haskell


Y Y FMC


immunotoxicity feeding study in mice DuPont Haskell


Published: No

Y Y FMC

IIA, 5.10/03 2010a Cyantraniliprole (DPX-HGW86) technical: Adrenal and

thyroid mechanistic: 90-day feeding study in rats DuPont




No

Y Y FMC

IIA, 5.10/04 2010b Cyantraniliprole (DPX-HGW86) technical: Adrenal

mechanistic study 90-day feeding study in mice DuPont




No

Y Y FMC

IIA, 5.8/22 2013 IN-M2G98: In vitro mammalian chromosome aberration test


Global Centers for Health & Environmental Sciences,

Alliance Pharma, Inc. DuPont-37573 GLP: Yes Published:

No

Y Y FMC

IIA, 5.8/23 2013 IN-M2G98: Bacterial reverse mutation test BioReliance


Y Y FMC




No

Y Y FMC



Environmental Sciences DuPont-33376, Supplement No. 1


Y Y FMC

IIA, 6.1.1/01 2010 Stability of DPX-HGW86 and metabolite/degredation

product residues in representative crops stored frozen ABC

Laboratories, Inc. DuPont-16990, Revision No. 1 GLP: Yes

Published: No

Y Y FMC

IIA, 6.2.1/01 2010 The metabolism of [14C]DPX-HGW86 in rice Charles River


Y Y FMC

IIA, 6.2.1/02 2008 The metabolism of [14C]DPX-HGW86 in cotton Charles

River Laboratories DuPont-16984, Revision No. 1 GLP: Yes

Published: No

Y Y FMC

IIA, 6.2.1/03 2008a The metabolism of [14C]DPX-HGW86 in tomatoes Charles


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 6.2.1/04 2008b The metabolism of [14C]DPX-HGW86 in lettuce Charles


Y Y FMC

IIA, 6.2.2/01 2008 The metabolism of [14C] DPX-HGW86 in the laying hen


Published: No

Y Y FMC

IIA, 6.2.3/01 2008 Metabolism of [14C] DPX-HGW86 in the lactating goat


Published: No

Y Y FMC

IIA, 6.3/01 2011a Cyantraniliprole residue analytical method concurrent

recoveries for commodities of plant and animal origin


No Published: No

N N FMC

IIA, 6.3/02 2011b Cyantraniliprole: Relative residues for different application

method treatment regimes DuPont Stine-Haskell Research

Center DuPont-30876 GLP: No Published: No

N N FMC

IIA, 6.3/03 2011c Cyantraniliprole formulated product residue bridging DuPont

Stine-Haskell Research Center DuPont-30877 GLP: No

Published: No

N N FMC

IIA, 6.3.1/01 2010 Magnitude and decline of DPX-HGW86 and metabolite

residues in field potatoes (potato group) following foliar

application of DPX-HGW86 100 g/L OD - Europe, 2008


Published: No

Y Y FMC

IIA, 6.3.1/02 2010 Combined processing and magnitude of cyantraniliprole and

metabolite residues in tuberous and corm vegetables

(potatoes) following foliar applications (DPX-HGW86 100

g/L OD and DPX-HGW86 100 g/L SE), soil applications

(DPX-HGW86 200 g/L SC), and seed treatment (625 g/L FS)

– NAFTA, 2009 ABC Laboratories, Inc. DuPont-27583 GLP:

Yes Published: No

Y Y FMC

IIA, 6.3.2/01 2010 HGW86: Magnitude of the residue on dry bulb and green

onion ABC Laboratories, Inc. DuPont-27436 GLP: Yes

Published: No

Y Y FMC

IIA, 6.3.3/01 2010 Magnitude and decline of cyantraniliprole and metabolite

residues in protected lettuce, lamb's lettuce, and scarole (leaf

vegetables) following foliar application of DPX-HGW86 100

g/L OD and soil application of DPX-HGW86 200 g/L SC -

Europe, 2009 initiation Charles River Laboratories DuPont-


Y Y FMC

IIA, 6.3.3/02 2010 Combined processing and magnitude and decline of DPX-

HGW86 and metabolite residues in leafy vegetables

(head/leaf lettuce, celery, spinach) following foliar

applications of DPX-HGW86 100 g/L, DPX-HGW86 100

g/L SE, soil applications of DPX-HGW86 200 g/L SC – U.S.

The Carringers, Inc.; ABC Laboratories, Inc. DuPont-25644

GLP: Yes Published:

Y Y FMC


residues in field-grown lettuce and sacrole following foliar

application of DPX-HGW86 100 g/L OD and soil application

of DPX-HGW86 200 g/L SC - France and southern Europe,

2009 initiation Charles River Laboratories DuPont-27713


Y Y FMC


residues in protected lettuce (leaf vegetablies) following

foliar application of DPX-HGW86 100 g/L OD or drip

irrigation application of DPX-HGW86 200 g/L SC- Europe,

2008 Charles River Laboratories DuPont-21415, Revision

No. 1 GLP: Yes Published: No

Y Y FMC

Benevia Part A


15569 N


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Owner


residues in brassica vegetables (broccoli/cauliflower,

cabbage, mustard greens) following foliar applications of

DPX-HGW86 100 g/L OD, DPX-HGW86 100 g/L SE, and

soil applications of DPX-HGW86 200 g/L SC – U.S. The

Carringers, Inc.; ABC Laboratories, Inc. DuPont-25641 GLP:

Yes Published: No

Y Y FMC


residues in protected green beens (fresh legume vegetables)

following foliar application of DPX-HGW86 100 g/L OD -

Europe, 2008 and 2009 Charles River Laboratories DuPont-


Y Y FMC


residues in field-grown green beans (fresh legume

vegetables) following foliar application of DPX-HGW86 100

g/L OD - France and Southern Europe, 2009 initiation


Published: No

Y Y FMC

IIA, 6.3.6/01 2010a Magnitude and decline of cyantraniliprole and metabolite

residues in protected cucumbers and courgettes (fruiting

vegetables, edible-peel cucurbits) following foliar appliaction

of DPX-HGW86 100 g/L OD and soil application of DPX-

HGW86 200 g/L SC - Europe, 2009 initiation Charles River


Y Y FMC

IIA, 6.3.6/02 2010b Magnitude and decline of cyantraniliprole and metabolite

residues in protected melons (fruiting vegetables, inedible-

peel cucurbits) following foliar application of DPX-HGW86

100 g/L OD and soil application of DPX-HGW86 200 g/L

SC - Europe, 2009 initiation Charles River Laboratories


Y Y FMC


residues in field grown melons, couurgettes and cumbers

(fruiting vegetables, inedible-peel cucurbits) following foliar

application of DPX-HGW86 100 g/L OD and soil application

of DPX-HGW86 200 g/L SC - France and sourthern Europe,



Y Y FMC


residues in cucurbits (cucumber, cantaloupe/muskmelon,

summer squash) following foliar applications of DPX-

HGW86 100 g/L OD and soil applications of DPX-HGW86

200 g/L SC - U.S. The Carringers, Inc.; ABC Laboratories,

Inc. DuPont-25642 GLP: Yes Published: No

Y Y FMC

IIA, 6.3.6/05 2010 Determination of Cyazypyr residues in cucurbit fruit

AgriSolutions Austrailia Pty Ltd DuPont-31413 GLP: Yes

Published: No

Y Y FMC


residues in protected tomatoes and cherry tomatoes (fruiting

vegetables, solanacea) following foliar application of DPX-

HGW86 100 g/L OD and soil application of DPX-HGW86

200 g/L SC - Europe, 2009 initiation Charles River


Y Y FMC

IIA, 6.3.7/02 2010 Magnitide and decline of DPX-HGW86 and metabolite

residues in fruiting vegetables (tomato, bell pepper, non-bell

pepper) following foliar application of DPX-HGW86 100 g/L

OD and soil applications of DPX-HGW86 200 g/L SC - U.S.

The Carringers, Inc.; ABC Laboratories, Inc. DuPont-25643


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner


residues in protected peppers (fruiting vegetables, solanacea)

following foliar application of DPX-HGW86 100 g/L OD or

drip irrigation application of DPX-HGW86 200 g/L SC -

Europe 2008 Charles River Laboratories DuPont-23885 GLP:

Yes Published: No

Y Y FMC


residues in field-grown tomatoes, peppers, and hot peppers

(fruiting vegetables, solanacea) following foliar application

of DPX-HGW86 100 g/L OD - Southern Europe, 2009

initiation Charles River Laboratories DuPont-27712 GLP:

Yes Published: No

Y Y FMC


residues in protected peppers and hot peppers (fruiting

vegetables, solanacea) following foliar application of DPX-

HGW86 100 g/L OD and soil application of DPX-HGW86

200 g/L SC - Europe, 2009 initiation Charles River


Y Y FMC

IIA, 6.3.7/06 2010 Determination of CyazypyrTM residues in tomato and

capsicum fruit AgriSolutions Austrailia Pty Ltd DuPont-


Y Y FMC

IIA, 6.3.8/01 2010 Combined processing and magnitude of DPX-HGW86 and

metabolite residues in citrus fruit (orange, lemon, and

grapefruit) following foliar applications of DPX-HGW86 100

g/L SE and systemic delivery applications of DPX-HGW86

200 g/L SC - USA, 2009 ABC Laboratories, Inc. DuPont-


Y Y FMC


residues in oranges and mandarins (citrus fruit) following

foliar application of DPX-HGW86 100 g/L SE - southern



Y Y FMC

IIA, 6.3.9/01 2010a SYN545377 - Residue study on apple in southern France and

Spain in 2009 Eurofins/ADME Bioanalyses S09-01572-Reg


Y Y FMC

IIA, 6.3.9/02 2010b SYN545377 - Residue study on apple in northern France and

Germany in 2009 Eurofins/ADME Bioanalyses S09-01571-

Reg GLP: Yes Published: No

Y Y FMC

IIA, 6.3.9/03 2011a Cyantraniliprole - Residue study on apples in northern

France, and Germany in 2010 Eurofins/ADME Bioanalyses

S10-01051 GLP: Yes Published: No

Y Y FMC

IIA, 6.3.9/04 2011b Cyantraniliprole - Residue study on apples in southern

France,in 2010 Eurofins/ADME Bioanalyses S10-01052-Reg

GLP: Yes Published: N

Y Y FMC


residues in apples and pears (pome fruit) following foliar

application of DPX-HGW86 100 g/L SE - Northern and

Southern Europe, 2009 initiation Charles River Laboratories


Y Y FMC

IIA, 6.3.9/06 2010a SYN5455377 - Residue study on pears in northern France

and Germany in 2009 Eurofins/ADME Bioanalysis S09-

01573-Reg GLP: Yes Published: No

Y Y FMC

IIA, 6.3.9/07 2010b SYN5455377 - Residue study on pears in southern France

and Spain in 2009 Eurofins/ADME Bioanalysis S09-01574-


Y Y FMC

IIA, 6.3.9/08 2011a Cyantraniliprole - Residue study on pears in northern France

and Germany in 2010 Eurofins/ADME Bioanalysis S10-


Y Y FMC

Benevia Part A


15569 N


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Owner

IIA, 6.3.9/09 2011b Cyantraniliprole - Residue study on pears in southern France

and Italy in 2010 Eurofins/ADME Bioanalysis S10-01054-


Y Y FMC

IIA, 6.3.9/10 2010 Combined processing and magnitude and decline of

cyantraniliprole and metabolite residues in pome fruit (apple

and pear) following foliar applications of DPX-HGW86 100

g/L SE - NAFTA, 2009 ABC Laboratories, Inc. DuPont-


Y Y FMC


residues in peaches and apricots (stone fruit) following foliar

application of DPX-HGW86 100 g/L SE - Southern Europe,



Y Y FMC

IIA, 6.3.10/02 2011a Cyantraniliprole - Residue study on plums in southern

France, and Spain in 2010 Eurofins/ADME Bioanalyses S10-


Y Y FMC

IIA, 6.3.10/03 2011b Cyantraniliprole - Residue study on plums in northern

France, and Germany in 2010 Eurofins/ADME Bioanalyses

S10-01056-Reg GLP: Yes Published: No

Y Y FMC

IIA, 6.3.10/04 2010 SYN545377 - Residue study on peaches in southern France,

Spain, and Italy in 2009 Eurofins/ADME Bioanalyses S09-


Y Y FMC

IIA, 6.3.10/05 2011 Cyantraniliprole - Residue study on peaches in southern

France, Italy, and Spain, in 2010 Eurofins/ADME

Bioanalyses S10-01055-Reg GLP: Yes Published: No

Y Y FMC

IIA, 6.3.10/06 2010a SYN545377 - Residue study on peaches in northern France,

and Germany in 2009 Eurofins/ADME Bioanalyses S09-


Y Y FMC

IIA, 6.3.10/07 2010b SYN545377 - Residue study on plums in southern France,

and Spain in 2009 Eurofins/ADME Bioanalyses S09-01578-


Y Y FMC


cyantraniliprole and metabolite residues in stone fruit (peach,

plum, and cherry) following foliar applications of DPX-

HGW86 100 g/L SE - NAFTA, 2009 ABC Laboratories, Inc.


Y Y FMC

IIA, 6.3.11/01 2010 Magnitude of cyantraniliprole and metabolite residues in

blueberries following foliar applications of DPX-HGW86

100 g/L SE - USA, 2009 ABC Laboratories, Inc. DuPont-


Y Y FMC

IIA, 6.3.11/02 2011 Cyantraniliprole: Magnitude of the residue on blueberry ABC

Laboratories, Inc. AAFC09-025R GLP: Yes Published: No

Y Y FMC


cyantraniliprole and metabolite residues in wine and table

grapes (berries and small fruit) following foliar application of

DPX-HGW86 100 g/L SE - northern and southern Europe,



Y Y FMC

IIA, 6.3.12/01 2010 Magnitude of cyantraniliprole and metabolite residues in tree

nuts (almonds and pecans) following foliar applications

(DPX-HGW86 100 g/L OD and DPX-HGW86 100 g/L SE)

and soil applications (DPX-HGW86-200 g/L SC) - NAFTA,

2009 ABC Laboratories, Inc. DuPont-27446 GLP: Yes

Published: No

Y Y FMC

IIA, 6.3.13/01 2010a Determination of CyazypyrTM residues in canola seed, oil and

trash (fodder) AgriSolutions Austrailia Pty Ltd DuPont-


Y Y FMC

Benevia Part A


15569 N


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Owner

IIA, 6.3.13/02 2010b To determine CyazypyrTM residues in cotton following two

applications of DPX-HGW86 100 SE applied at a 7 day

interval AgriSolutions Austrailia Pty Ltd DuPont-31410


Y Y FMC

IIA, 6.3.13/03 2010a Combined processing and magnitude of cyantraniliprole and

metabolite residues in oil seeds (canola and sunflowers)

following foliar applications of DPX-HGW86 100 g/L OD

and seed treatment with 625 g/L FS - NAFTA, 2009 ABC


Y Y FMC

IIA, 6.3.13/04 2010b Combined processing and magnitude of cyantraniliprole and

metabolite residues in cotton following foliar applications of

DPX-HGW86 100 g/L OD and soil applications of DPX-

HGW86 200 g/L SC - USA, 2009 ABC Laboratories, Inc.


Y Y FMC


cyantraniliprole and metabolite residues in olives following



27709 GLP: Yes Published: N

Y Y FMC

IIA, 6.3.15/01 2012 Residue test report of cyantraniliprole on the rice field Institut

of Quality and Standard fo rAgro-products, Zhejiang

Academy of Agricultural Sciences CL-2010-026 GLP: Yes

Published: No

Y Y FMC

IIA, 6.3.16/01 2011 Study of the residues of the insecticide DPX-HGW86 20%

SC and DPX-HGW86 10% OD (cyantraniliprole) in coffee

culture (Coffee arabica) 2010-2011 field season DuPont do

Brazil S/A, Paulina SP, Brazil and JM Bioanalises (BPL

0024), Botucato SP, Brazil BRI-10/11-008 GLP: Yes

Published: No

Y Y FMC

IIA, 6.4.1/01 2011 Magnitude of residues of cyantraniliprole (DPX-HGW86)

and metabolites in edible tissues and eggs of poultry

following dosing with cyantraniliprole Charles River


Y Y FMC

IIA, 6.4.2/01 2011 DPX-HGW86: Magnitude of residues of cyantraniliprole

(DPX-HGW86) and metabolites in edible tissues and milk of

lactating diary cows following dosing with cyantraniliprole

Charles River Laboratories DuPont-27180, Revision No. 1


Y Y FMC

IIA, 6.5.1/01 2005 High temperature hydrolysis of [14C]-DPX-HGW86 in

buffered aqueous solution at pH 4, 5, and 6 Charles River


Y Y FMC

IIA, 6.5.4/01 2009 Magnitude of DPX-HGW86 and metabolite residues in

processed fractions of tomatoes following foliar applications

of DPX-HGW86 100 g/L OD - U.S., 2008 The Carringers,

Inc.; ABC Laboratories, Inc. DuPont-25645 GLP: Yes

Published: No

Y Y FMC

IIA, 6.5.4/02 2010 Combined processing and magnitude and decline of DPX-

HGW86 and metabolite residues in leafy vegetables

(head/leaf lettuce, celery, spinach) following foliar

applications of DPX-HGW86 100 g/L OD, DPX-HGW86

100 g/L SE, and soil applications of DPX-HGW86 200 g/L

SC - U.S. The Carringers, Inc.; ABC Laboratories, Inc.


Y Y FMC

IIA, 6.5.4/03 2010 Combined processing and magnitude of DPX-HGW86 and

metabolite residues in citrus fruit (orange, lemon, and

grapefruit) following foliar applications of DPX-HGW86 100

g/L SE and systemic delivery applications of DPX-HGW86

200 g/L SC - USA, 2009 ABC Laboratories, Inc. DuPont-


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 6.5.4/04 2010a Combined processing and magnitude and decline of

cyantraniliprole and metabolite residues in stone fruit (peach,

plum, and cherry) following foliar applications of DPX-

HGW86 100 g/L SE - NAFTA, 2009 ABC Laboratories, Inc.


Y Y FMC

IIA, 6.5.4/05 2010b Combined processing and magnitude of cyantraniliprole and

metabolite residues in cotton following foliar applications of

DPX-HGW86 100 g/L OD and soil applications of DPX-

HGW86 200 g/L SC - USA, 2009 ABC Laboratories, Inc.


Y Y FMC

IIA, 6.5.4/06 2010c Combined processing and magnitude and decline of

cyantraniliprole and metabolite residues in pome fruit (apple

and pear) following foliar applications of DPX-HGW86 100

g/L SE - NAFTA, 2009 ABC Laboratories, Inc. DuPont-


Y Y FMC

IIA, 6.5.4/07 2010d Combined processing and magnitude of cyantraniliprole and

metabolite residues in tuberous and corm vegetables

(potatoes) following foliar applications (DPX-HGW86 100

g/L OD and DPX-HGW86 100 g/L SE), soil applications

(DPX-HGW86 200 g/L SC), and seed treatment (625 g/L FS)

– NAFTA, 2009 ABC Laboratories, Inc. DuPont-27583 GLP:

Yes Published: No

Y Y FMC


cyantraniliprole and metabolite residues in olives following




Y Y FMC

IIA, 6.6.2/01 2012 Confined rotational crop study using [14C] DPX-HGW86



Y Y FMC

IIA, 6.6.2/02 2006 [14C]DPX-HGW86 pilot confined crop rotation study

(wheat, soybeans, and red beets) DuPont Stine-Haskell

Research Center DuPont-15513 GLP: No Published: No

N N FMC

IIA, 6.6.2/03 2012 DuPont/Syngenta responses to ANSES concerns regarding

the confined rotational crop study of cyantraniliprole as part

of the global joint review DuPont Stine-Haskell Research

Center DuPont-36046 EU GLP: No Published: No

N N FMC


and/or degradation product residues in field rotational crops

following foliar application of DPX-HGW86 100 g/L OD –

northern Europe, 2008 and 2009 Charles River Laboratories


Y Y FMC

IIA, 6.6.3/02 2010 Field crop rotation study with DPX-HGW86 insecticide -

southern Europe 2006–2009 Charles River Laboratories


Y Y FMC

IIA, 6.6.3/03 2009a Field crop rotation study with DPX-HGW86 10OD

insecticide - EPA region 11, USA, 2006 ABC Laboratories,

Inc. DuPont-19640 GLP: Yes Published: No

Y Y FMC

IIA, 6.6.3/04 2009b Field crop rotation study with DPX-HGW86 10OD

insecticide - EPA region 10, USA, 2006 ABC Laboratories,

Inc. DuPont-19639 GLP: Yes Published: N

Y Y FMC

IIA, 6.6.3/05 2010a Magnitude of DPX-HGW86 and metabolite and/or

degradation product residues in field rotational crops

following application of DPX-HGW86 100 g/L OD

insecticide - Ontario, Canada location 2008/2009 ABC


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 6.6.3/06 2011 Magnitude of cyantraniliprole and metabolite residues in field

rotational crops following bare ground applications of DPX-

HGW86 100 g/L SE - USA and Canada, 2010 ABC


Y Y FMC

IIA, 6.6.3/07 2010b Magnitude of cyantraniliprole and metabolite residues in field

rotational crops following bare ground applications of DPX-

100 g/L SE - USA, 2009 ABC Laboratories, Inc. DuPont-


Y Y FMC

IIA, 6.7/01 2011a Cyantraniliprole relevant residues including parent equivalent

residue calculations for commodities of plant and animal

origin DuPont Stine-Haskell Research Center DuPont-27796

GLP: Not applicable position paper Published: No

N N FMC

IIA, 6.7/02 2011b Cyantraniliprole residue population assessments as inputs to

maximum residue level and residue dietary exposure

estimates DuPont Stine-Haskell Research Center DuPont-

30878 GLP: Not applicable position paper Published: No

N N FMC

IIA, 6.9/01 2011 Dietary risk assessments in support of Annex I inclusion and

maximum residue levels or import tolerances for

cyantraniliprole in Europe - food commodities Stine-Haskell

Research Center DuPont-29234 EU, Revision No. 1 GLP:

Not applicable position paper Published: No

N N FMC

IIA, 6.10/01 2010a Dissipation of dislodgeable foliar residues of DPX-HGW86


to apple trees ABC Laboratories, Inc. DuPont-27935 GLP:

Yes Published: No

Y Y FMC

IIA, 6.10/02 2010b Dissipation of dislodgeable foliar residues of DPX-HGW86


to lettuce ABC Laboratories, Inc. DuPont-27936 GLP: Yes

Published: No

Y Y FMC

IIA, 6.10/03 2012 Dupont/Syngenta responses to ANSES concerns regarding

the metabolism, residue and environmental fate of

cyantraniliprole as part of the global joint review DuPont

Stine-Haskell Research Center DuPont-34488 EU GLP: No

Published: No

N N FMC

IIA, 6.2.2/01 2008 The metabolism of [14C] DPX-HGW86 in the laying hen


Published: No

Y Y FMC

IIA, 6.2.3/01 2008 Metabolism of [14C] DPX-HGW86 in the lactating goat


Published: No

Y Y FMC

IIA, 6.4.1/01 2011 Magnitude of residues of cyantraniliprole (DPX-HGW86)

and metabolites in edible tissues and eggs of poultry

following dosing with cyantraniliprole Charles River


Y Y FMC

IIA, 6.4.2/01 2011 DPX-HGW86: Magnitude of residues of cyantraniliprole

(DPX-HGW86) and metabolites in edible tissues and milk of

lactating diary cows following dosing with cyantraniliprole



Y Y FMC

IIA, 7.1.1/01 2006 Route of degradation and sorption of [14C]-DPX-HGW86 in

two aerobic soils DuPont Stine-Haskell Research Center


Y Y FMC

IIA, 7.1.2/01 2006 Anaerobic soil metabolism of [14C]-DPX-HGW86 Charles


Y Y FMC

IIA, 7.1.3/01 2005 Photodegradation of [14C]-DPX-HGW86 on soil Charles


Y Y FMC

Benevia Part A


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Owner

IIA 7.1.3/02 2010 Photodegradation of [14C]-DPX-HGW86 on moist soil


Published: No

Y Y FMC

IIA, 7.2.1/01 2006 Rate of degradation and aged desorption of [14C]-DPX-

HGW86 in three aerobic soils Charles River Laboratories


Y Y FMC




Y Y FMC

IIA, 7.2.3/01 2008 Rate of degradation [14C]-IN-PLT97 in five aerobic soils


Yes Published: No

Y Y FMC

IIA, 7.2.3/02 2006 Rate of degradation of [14C]-IN-J9Z38 in five aerobic soils


Published: No

Y Y FMC

IIA, 7.2.3/03 2010 Rate of degradation [14C]-IN-RNU71 in five aerobic soils



Y Y FMC

IIA, 7.2.3/04 2007a Rate of degradation of [14C]-IN-K5A78 in five aerobic soils


Published: No

Y Y FMC

IIA, 7.2.3/05 2007b Rate of degradation of [14C]-IN-JSE76 in five aerobic soils


Published: No

Y Y FMC

IIA, 7.2.3/06 2006 Rate of degradation of [14C]-IN-K5A77 in five aerobic soils


Published: No

Y Y FMC

IIA, 7.2.3/07 2008 Rate of degradation of [14C]-IN-K5A79 in five aerobic soils


Yes Published: No

Y Y FMC

IIA, 7.2.3/08 2007 Rate of degradation of [14C]-IN-JCZ38 in five aerobic soils


Published: No

Y Y FMC

IIA, 7.2.3/09 2010 Rate of degradation [14C]-IN-QKV54 in five aerobic soils


Published: No

Y Y FMC

IIA, 7.2.3/10 2012 The degradation and adsorption parameters proposed for use

in environmental exposure assessment of the metabolite IN-

M2G98 DuPont-35754, Revision No.1 GLP: No Published:

No

N Y FMC

IIA, 7.2.3/11 2012 Degradation of pyridine and benzamide rings in DPX-

HGW86 DuPont-35733 GLP: No Published: No

N Y FMC

IIA, 7.3.1/01 2010a Field soil dissipation of DPX-HGW86 following a single

application to bare ground - southern Europe (Italy) Charles


Y Y FMC

IIA, 7.3.1/02 2010b Field soil dissipation of DPX-HGW86 following a single

application to bare ground - northern Europe (Germany)



Y Y FMC

IIA, 7.3.1/03 2010a Field soil dissipation of DPX-HGW86 following a single

application to bare ground - southern Europe (Spain) Charles


Published: No

Y Y FMC

IIA, 7.3.1/04 2010b Field soil dissipation of DPX-HGW86 following a single

application to bare ground - northern Europe (France)

Charles River Laboratories DuPont-17062, Revision No.1


Y Y FMC

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Owner

IIA, 7.3.1/05 2010 Freezer storage stability of DPX-HGW86 and its photolysis

degradation products DuPont Stine-Haskell Research Center


N Y FMC

IIA, 7.3.1/06 2010 Storage stability of DPX-HGW86 and metabolites (IN-

JCZ28, IN-K5A77, IN-K5A78, IN-K5A79, IN-J9Z38, IN-

JSE76, IN-PLT97) in frozen soil ABC Laboratories, Inc.


Y Y FMC

IIA, 7.3.1/07 2008 Terrestrial field dissipation of DPX-HGW86 insecticide on

bare soil and in the presence of a leafy vegetable crop in

California, USA ABC Laboratories, Inc. DuPont-17066 GLP:

Yes Published: No

Y Y FMC

IIA, 7.3.1/08 2009a Terrestrial field dissipation of DPX-HGW86 insecticide on

bare soil and in the presence of an alfalfa crop in Missouri,

USA ABC Laboratories, Inc. DuPont-17067 GLP: Yes

Published: No

Y Y FMC

IIA, 7.3.1/09 2009b Terrestrial field dissipation of DPX-HGW86 insecticide on

bare soil and in the presence of a potato crop in Washington,

USA ABC Laboratories, Inc. DuPont-17065, Revision No. 1


Y Y FMC

IIA, 7.3.1/10 2010 Assessment of the global environmental conditions and soil

characteristics in relation to cyantraniliprole (DPX-HGW86)

field and laboratory studies Waterborne Environmental, Inc.

(WEI) DuPont-28155 GLP: No Published: No

N Y FMC

IIA, 7.3.1/11 2010 Field dissipation of cyantraniliprole (DPX-HGW86) in North

America and Europe - summary of normalized kinestic

calculations Waterborne Environmental, Inc. DuPont-31454


N Y FMC

IIA, 7.3.1/12 2010a Terrestrial field dissipation of DPX-HGW86 on bare soil in

Texas, USA ABC Laboratories, Inc. DuPont-17457, Revision


Y Y FMC

IIA, 7.3.1/13 2010b Terrestrial field dissipation of DPX-HGW86 on bare soil in

New York, USA ABC Laboratories, Inc. DuPont-17064


Y Y FMC

IIA, 7.3.1/14 2010c Terrestrial field dissipation of DPX-HGW86 on bare soil in

Manitoba, Canada ABC Laboratories, Inc. DuPont-17068


Y Y FMC

IIA, 7.3.1/15 2010a Analysis of photolysis products of DPX-HGW86 in field soil

dissipation samples - North America ABC Laboratories, Inc.


Y Y FMC

IIA, 7.3.1/16 2010b Analysis of photolysis products of DPX-HGW86 in field soil

dissipation samples - EU studies ABC Laboratories, Inc.


Y Y FMC




Y Y FMC

IIA, 7.4.1/02 2006 Route of degradation and sorption of [14C]-DPX-HGW86 in

two aerobic soils DuPont Stine-Haskell Research Center


Y Y FMC

IIA, 7.4.1/03 2007 [14C]-DPX-HGW86: Batch equilibrium

adsorption/desorption) in five soils Charles River


Y Y FMC

IIA, 7.4.2/01 2008 Rate of degradation of [14C]-IN-PLT97 in five aerobic soils


Yes Published: No

Y Y FMC

IIA, 7.4.2/02 2007 [14C]-IN-J9Z38 (a metabolite of DPX-HGW86): Batch

equilibrium (adsorption/desorption) in five soils Charles


Y Y FMC

Benevia Part A


15569 N


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Owner

IIA, 7.4.2/03 2010 IN-K5A78 (a metabolite of DPX-HGW86): Batch

equilibrium (adsorption/desorption) in five soils Charles

River Laboratories DuPont-17606, Revsion No.1 GLP: Yes

Published: No

Y Y FMC

IIA, 7.4.2/04 2010 [14C]-IN-RNU71 a metabolite of [14C]-DPX-HGW86:

Batch equilibrium adsorption/desorption in five soils Charles


Y Y FMC

IIA, 7.4.2/05 2007 IN-JSE76 (a metabolite of DPX-HGW86): Batch equilibrium

(adsorption/desorption) in five soils Charles River


Y Y FMC

IIA, 7.4.2/06 2010 Adsorption-desorption of [14C]-IN-K5A79 in five soils by

batch equilibrium DuPont Stine-Haskell Research Center


Y Y FMC

IIA, 7.4.2/07 2006a [14C]-IN-K5A77 (a metabolite of [14C]-DPX-HGW86):

Batch equilibrium (adsorption/desorption) in five soils


Published: No

Y Y FMC

IIA, 7.4.2/08 2006b [14C]-IN-JCZ38 (a metabolite of [14C]-DPX-HGW86):



Published: No

Y Y FMC

IIA, 7.4.2/09 2010 [14C]-IN-QKV54 a metabolite of [14C]-DPX-HGW86:

Batch equalibrium adsorption/desorption in five soils Charles


Y Y FMC

IIA, 7.4.2/10 2007 [14C]-IN-PLT97 (a metabolite of [14C]-DPX-HGW86):



Published: No

Y Y FMC

IIA, 7.4.2/11 2012 The degradation and adsorption parameters proposed for use

in environmental exposure assessment of the metabolite IN-

M2G98 DuPont-35754, Revision No.1 GLP: No Published:

No

N Y FMC

IIA, 7.5/01 2005 Hydrolytic stability of [14C]-DPX-HGW86 in buffered

aqueous solutions at pH 4, 7, and 9 Inveresk Research

International (IRI) Limited DuPont-17058 GLP: Yes

Published: No

Y Y FMC

IIA, 7.6/01 2007 Photodegradation of [14C]-DPX-HGW86 in pH 4 buffer and



Y Y FMC

IIA, 7.6/02 2010 Supplement to photodegredation of [14C]-DPX-HGW86 in

pH 4 buffer and natural water, identification of IN-RNU71


No Published: No

N N FMC

IIA, 7.7/01 2008 DPX-HGW86: Laboratory study of ready biodegradability:

CO2 evolution test Advinus Therapeutics Private Limited


Y Y FMC

IIA, 7.8.1/01 2010 Fate of [14C]-DPX-HGW86 in flooded aerobic soil Charles


Published: No

Y Y FMC

IIA, 7.8.1/02 2006 [14C]-DPX-HGW86: Degradability and fate in the

sediment/water system Charles River Laboratories DuPont-


Y Y FMC

IIA, 7.8.2/01 2010 Anaerobic aquatic metabolism of [14C]-DPX-HGW86 in a

water/sediment system Charles River Laboratories DuPont-


Y Y FMC

IIA, 7.8.2/02 2010 Anaerobic aquatic metabolism of 14C-DPX-HGW86 in a

water-sediment system DuPont Stine-Haskell Research

Center DuPont-18869, Revision No. 1 GLP: Yes Published:

No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 7.8.3/01 2010 Outdoor water sediment study (aerobic aquatic metabolism)

of [14C]-DPX-HGW86 Charles River Laboratories DuPont-

24798, Revision No. 1 GLP: Yes Published: No

Y Y FMC

IIA, 7.2/01 1987 Microbial metabolism of homocyclic and heterocyclic

aromatic compounds under Anaerobic conditions Microbiol.

Reviews Vol 51(1) 43-59 (1987) GLP: No Published: Yes

N N FMC

IIA, 7.2/02 1991 The transformation of heterocyclic aromatic compounds and

their derivatives under anaerobic conditions Pennsylvania

State, University Environmen. Contrl. Vol 21(3-4) 297-329

(1991) GLP: No Published: Yes

N N FMC

IIA, 7.2/03 1994 Microbial transformation of ethylpyridines Biodegradations

Vol 5(2) 121-128 (1994) GLP: No Published: Yes

N N FMC

IIA, 7.2/04 1980 A correlation study of biodegradability determinations with

various chemicals in various tests Department of Ecology

Ecotoxicol. Environ. Saf. Vol 5 45-55 (1981) GLP: No

Published: Yes

N N FMC

IIA, 7.2/05 1990 Anaerobic microbial transformation of nonoxygenated

aromatic and alicyclic compounds in soil, subsurface, and

freshwater sediments Soil Biochemistry Vol 6, 117-189

(1990) by Bollag and Stotzky GLP: No Published: Yes

N N FMC

IIA, 7.2/06 1972 Microbial metabolism of the pyridine ring University of New

Castle upon Tyne Biochem. J. 130 879-893 (1972) GLP: No

Published: Yes

N N FMC

IIA, 7.2/07 1979 Microbiological transformation of pyridine derivatives

(review) Chem. Heterocycl. Compd. Vol 14(10) 1049-1062

(1979) GLP: No Published: Yes

N N FMC

IIA, 7.2/08 1993 Transformation of 3- and 4-picoline under sulfate-reducing

conditions Pennsylvania State, University Applied and

Environ. Microbiol. Vol 59(3) 701-705 (1993) GLP: No

Published: Yes

N N FMC

IIA, 7.2/09 2010 A novel soil bacterial strain degrading pyridines

Enviromental Chemistry Letters 9(3) 439-445 (2011) GLP:

No Published: Yes

N N FMC

IIA, 7.2/10 1948 The utilization of pyridine by micro-organisms J. Gen.

Microb. Vol 3 143-147 (1949) GLP: No Published: Yes

N N FMC

IIA, 7.2/11 1965 Photochemical degradation of paraquat Microbiol. Reviews

Vol 51(1) 43-59 (1987) GLP: No Published: Yes

N N FMC

IIA, 7.2/12 1978 The scientific aspects of chemical substance control law in

Japan Ministry of Intl Trade and Industry 283-298 (1978)

GLP: No Published: Yes

N N FMC

IIA, 7.3/02a 2014 pH dependence of cyantraniliprole DuPont Stine-Haskell

Research Center DuPont-39294 EU GLP: No Published: No

N N FMC

IIA, 7.3/03a 2014 Further kinetic analyses for degradation of cyantraniliprole in

Tama and Lleida soils: Verification via full pathway kinetic

fit DuPont Stine-Haskell Research Center DuPont-39295 EU


N N FMC

IIA, 7.3/04a 2014 Evidences for plant uptake of cyantraniliprole (DPX-

HGW86) by crops from soils under greenhouse and field

conditions DuPont Stine-Haskell Research Center DuPont-

39549 EU GLP: No Published: No

Y Y FMC

IIA, 8.1.1/01 2008 DPX-HGW86 technical: An acute oral toxicity study with the

northern bobwhite Wildlife International, Ltd. DuPont-24248


Y Y FMC

IIA, 8.1.1/02 2009 Cyantraniliprole technical: An acute oral toxicity study with

the zebra finch (Poephila guttata) Wildlife International, Ltd.


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.1.2/01 2008 DPX-HGW86 technical: A dietary LC50 study with the



Y Y FMC


mallard Wildlife International, Ltd. DuPont-21469 GLP: Yes

Published: No

Y Y FMC

IIA, 8.1.4/01 2008a DPX-HGW86 technical: A reproduction study with the


Published: No

Y Y FMC

IIA, 8.1.4/02 2008b DPX-HGW86 technical: A reproduction study with the



Y Y FMC

IIA, 8.2/01 2012 Responses to regulatory review of ecotoxicology section


No Published No

N N FMC

IIA,

8.2.1.1/01

2006 DPX-HGW86 technical: Static, acute, 96-hour toxicity test

with rainbow trout, Oncorhynchus mykiss DuPont Haskell


Y Y FMC

IIA,

8.2.1.2/01

2009a Cyantraniliprole (DPX-HGW86) technical: A 96-hour flow-

through acute toxicity test with the channel catfish (Ictalurus

punctatus) Wildlife International, Ltd. DuPont-19167 GLP:

Yes Published: No

Y Y FMC

IIA,

8.2.1.2/02

2009b Cyantraniliprole technical: A 96-hour flow-through acute

toxicity test with the sheepshead minnow (Cyprinodon

variegatus) Wildlife International, Ltd. DuPont-19165 GLP:

Yes Published: No

Y Y FMC

IIA,

8.2.1.2/03

2006 DPX-HGW86 technical: Static-renewal, acute, 96-hour

toxicity test to bluegill sunfish, Lepomis macrochirus DuPont


Y Y FMC

IIA, 8.2.4/01 2009 Cyantraniliprole (DPX-HGW86) technical: An early life-

stage toxicity test with the sheepshead minnow (Cyprinodon


Yes Published: No

Y Y FMC

IIA, 8.2.4/02 2007 DPX-HGW86 technical: Early life-stage toxicity to rainbow

trout, Oncorhynchus mykiss DuPont Haskell Laboratories


Y Y FMC

IIA,

8.2.6.1/01

2010 14C-DPX-HGW86: Bioconcentration in bluegill sunfish,

Lepomis macrochirus ABC Laboratories, Inc. DuPont-21985


Y Y FMC

IIA, 8.3.1/01 2011 Cyantraniliprole: Rationale for selection of acute and chronic

aquatic invertebrate endpoints DuPont Stine-Haskell

Research Center DuPont-31209 GLP: No Published: No

N N FMC

IIA,

8.3.1.1/01

2008a Static, acute 48-hour toxicity of IN-JSE76 to the cladoceran,

Daphnia magna International Institute of Biotechnology and


Y Y FMC

IIA,

8.3.1.1/02

2008b Static-renewal, acute 48 hour toxicity test of IN-PLT97 to the

cladoceran, Daphnia magna International Institute of


Yes Published: No

Y Y FMC

IIA,

8.3.1.1/03

2010 IN-QKV54: Static, acute, 48-hour toxicity test with the

cladoceran, Daphnia magna DuPont Haskell Laboratories


Y Y FMC

IIA,

8.3.1.1/04

2010 IN-RNU71: 48-hour static, acute toxicity with cladoceran

Daphnia magna Springborn Smithers Laboratories DuPont-


N N FMC

IIA,

8.3.1.1/05

2008a Static-renewal, acute 48 hour toxicity test of IN-JCZ38 to the



Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA,

8.3.1.1/06

2008b Static, acute 48 hour toxicity test of IN-K5A79 to the



Yes Published: No

Y Y FMC

IIA,

8.3.1.1/07

2008c Static-renewal, acute 48 hour limit test of IN-K5A78 to the



Yes Published: No

Y Y FMC

IIA,

8.3.1.1/08


with Daphnia magna DuPont Haskell Laboratories DuPont-


Y Y FMC

IIA,

8.3.1.1/09

2009 IN-NXX70: Static, acute, 48-hour toxicity test with the

cladoceran, Daphia magna DuPont Haskell Laboratories


Y Y FMC

IIA,

8.3.1.1/10

2008a Static, acute 48-hour limit test of IN-J9Z38 to the cladoceran,

Daphnia magna Korea Institute of Toxicology, Korea

Research Institute of Chemical Technology DuPont-21321


Y Y FMC

IIA,

8.3.1.1/11

2008b Static, acute 48-Hour limit test of IN-K5A77 to the

cladoceran, Daphnia magna Korea Institute of Toxicology,

Korea Research Institute of Chemical Technology DuPont-


Y Y FMC

IIA,

8.3.1.1/12

2006 Acute toxicity test with IN-DBC80 in Daphnia magna



Y Y FMC

IIA,

8.3.1.2/01

2006a DPX-HGW86 technical: Static, acute, 48-hour toxicity test to

Soyedina carolinensis DuPont Haskell Laboratories DuPont-


Y Y FMC

IIA,

8.3.1.2/02

2006b DPX-HGW86 technical: Static, acute, 48-hour toxicity test to

the mayfly, Centroptilium triangulifer DuPont Haskell


Y Y FMC

IIA,

8.3.1.2/03


with Lepidostoma ontario DuPont Haskell Laboratories


Y Y FMC

IIA,

8.3.1.3/01

2006 DPX-HGW86 technical: A 96-hour flow-through toxicity test

with the saltwater mysid (Americamysis bahia) Wildlife


N N FMC

IIA,

8.3.1.3/02

2009 Cyantraniliprole (DPX-HGW86) technical: A 48-hour static-

renewal acute toxicity test with the crayfish (Procambarus

clarkii) Wildlife International, Ltd. DuPont-19194 GLP: Yes

Published: No

N N FMC

IIA,

8.3.1.3/03

2006a DPX-HGW86 technical: Static, acute, 48-hour toxicity test to

Hyalella azteca DuPont Haskell Laboratories DuPont-18436


N N FMC

IIA,

8.3.1.3/04

2006b DPX-HGW86 technical: Static, acute, 48-hour toxicity test to

Gammarus pseudolimnaeus DuPont Haskell Laboratories


N N FMC

IIA,

8.3.1.4/01

2006 DPX-HGW86: A 96-hour shell deposition test with the

eastern oyster (Crassostrea virginica) Wildlife International,

Ltd. DuPont-17466 GLP: Yes Published: No

Y Y FMC

IIA,

8.3.2.1/01

2006 DPX-HGW86: A flow-through life-cycle toxicity test with

the saltwater mysid (Americamysis bahia) Wildlife


Y Y FMC

IIA,

8.3.2.1/02

2004 Results of Ceriodaphnia chronic toxicity testing with DPX-

HGW86 EA Engineering, Science, and Technology, Inc.


N N FMC

IIA,

8.3.2.1/03

2006 DPX-HGW86 technical: 21-day chronic static-renewal

toxicity test to Daphnia magna DuPont Haskell Laboratories


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA,

8.3.2.1/04

2009a IN-J9Z38: 21-day chronic static-renewal toxicity test to




Y Y FMC

IIA,

8.3.2.1/05

2009b IN-K5A77: 21-day chronic static-renewal toxicity test to




Y Y FMC

IIA, 8.4/01 2009a Cyantraniliprole (DPX-HGW86) technical: A 96-hour

toxicity test with the freshwater alga (Anabaena flos-aquae)

Wildlife International, Ltd. DuPont-24876 GLP: Yes

Published: No

Y Y FMC

IIA, 8.4/02 2009b Cyantraniliprole (DPX-HGW86) technical: A 72-hour

toxicity test with the freshwater alga (Pseudokirchneriella

subcapitata) Wildlife International, Ltd. DuPont-19190 GLP:

Yes Published: No

Y Y FMC

IIA, 8.4/03 2009c Cyantraniliprole (DPX-HGW86) technical: A 96-hour

toxicity test with the marine diatom (Skeletonema costatum)


Published: No

Y Y FMC

IIA, 8.4/04 2009d Cyantraniliprole (DPX-HGW86) technical: A 96-hour

toxicity test with the freshwater, diatom, Navicula pelliculosa


Published: No

Y Y FMC

IIA, 8.5.1/01 2006a DPX-HGW86 technical: Static, acute, 48-hour toxicity test to

the aquatic oligochaete, Lumbriculus variegatus DuPont


Y Y FMC

IIA, 8.5.1/02 2006b DPX-HGW86 technical: Static, acute, 48-hour toxicity test to

Chironomus riparius DuPont Haskell Laboratories DuPont-


Y Y FMC

IIA, 8.5.2/01 2007a 14C-DPX-HGW86: A prolonged sediment toxicity test with

Chironomus riparius using spiked water Wildlife


Y Y FMC

IIA, 8.5.2/02 2007b 14C-DPX-HGW86: A prolonged sediment toxicity test with

Chironomus riparius using spiked sediment Wildlife

International, Ltd. DuPont-17463, Revision No.1 GLP: Yes

Published: No

Y Y FMC

IIA, 8.6/01 2009 Cyantraniliprole (DPX-HGW86) technical: A 7-day static-

renewal toxicity test with duckweed (Lemna gibba G3)


Published: No

Y Y FMC

IIA, 8.7.1/01 2008 DPX-HGW86 200 g/L SC: Acute oral and contact toxicity to

the honeybee, Apis mellifera L. International Institute of


Yes Published: No

Y Y FMC

IIA, 8.7.1/02 2005 DPX-HGW86 technical: Acute oral and contact toxicity to

the honeybee, Apis mellifera L. GAB Biotechnologie GmbH

& GAB Analytik GmbH DuPont-17000 GLP: Yes Published:

No

Y Y FMC

IIA, 8.7.1/03 2009a Cyantraniliprole (DPX-HGW86) 100 g/L SE: Acute oral and

contact toxicity to the honey bee, Apis mellifera L. eurofins-

GAB GmbH DuPont-25995 GLP: Yes Published: No

Y Y FMC

IIA, 8.7.1/04 2009b DPX-HGW86 OD, DPX-HGW86 OD + codacide, DPX-

HGW86 SE. DPX-HGW86 SE + codacide and codacide:

Comparative acute oral and contact toxicity to the honeybee

Apis mellifera L. in the laboratory (non-GLP study) eurofins-

GAB GmbH DuPont-27977 GLP: No Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.7.1/05 2009c IN-J9Z38: Acute oral toxicity to the honey bee, Apis

mellifera L. eurofins-GAB GmbH DuPont-27449 GLP: Yes

Published: No

Y Y FMC

IIA, 8.7.1/06 2009d IN-HGW87: Acute oral toxicity to the honey bee, Apis

mellifera L. eurofins-GAB GmbH DuPont-27448 GLP: Yes

Published: No

Y Y FMC

IIA, 8.7.1/07 2009e IN-HGW87: Acute effects to the honey bee, Apis mellifera L.

at low dose levels eurofins-GAB GmbH DuPont-29021 GLP:

Yes Published: No

Y Y FMC

IIA, 8.7.1/08 2007 DPX-HGW86 100 g/L OD: Acute oral and contact toxicity to

the honey bee, Apis mellifera L. eurofins-GAB GmbH


Y Y FMC

IIA, 8.7.1/09 2009 IN-K5A78: Acute oral toxicity to the honey bee, Apis

mellifera L International Institute of Biotechnology and


Y Y FMC

IIA, 8.7.2/01 2008 DPX-HGW86 200 g/L SC: Acute oral and contact toxicity to

the honeybee, Apis mellifera L. International Institute of


Yes Published: No

Y Y FMC

IIA, 8.7.2/02 2005 DPX-HGW86 technical: Acute oral and contact toxicity to

the honeybee, Apis mellifera L. GAB Biotechnologie GmbH

& GAB Analytik GmbH DuPont-17000 GLP: Yes Published:

No

Y Y FMC

IIA, 8.7.2/03 2009 Cyantraniliprole (DPX-HGW86) 100 g/L SE: Acute oral and

contact toxicity to the honey bee, Apis mellifera L. eurofins-


Y Y FMC

IIA, 8.7.2/04 2007 DPX-HGW86 100 g/L OD: Acute oral and contact toxicity to

the honey bee, Apis mellifera L. eurofins-GAB GmbH


Y Y FMC

IIA, 8.7.3/01 2010 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus Codacide

oil: A study to evaluate effects on the honey bee (Apis

mellifera L.; Hymenoptera, Apidae) under semi-field

conditions applied after daily bee-flight in Phacelia

tanacetifolia L. with additional asses BioChem agrar, Labor

für biologische und chemische Analytik GmbH DuPont-


Y Y FMC

IIA, 8.7.3/02 2010a DPX-HGW86 20SC and DPX-HGW86 10OD: A greenhouse

study to evaluate effects on the bumble bee (Bombus

terrestris L; Hymenoptera, Apidae) in tomato in Spain in

2009 Eurofins Agrosciences Services GmbH DuPont-27325


Y Y FMC

IIA, 8.7.3/03 2010b Cyantraniliprole 100 g/L SE plus Codacide oil: A semi-field

study to evaluate effects on the honey bee (Apis mellifera;

Hymenoptera, Apidae) in nectarines in Spain 2010 Eurofins

Agroscience Services GmbH DuPont-29812 GLP: Yes

Published: No

Y Y FMC

IIA, 8.7.3/04 2010c DPX-HGW86 100SE plus Codacide oil: A semi-field study

to evaluate effects on the honey bee (Apis mellifera;

Hymenoptera, Apidae) in apple in Spain 2009 Eurofins


Published: No

Y Y FMC

IIA, 8.7.3/05 2011a Cyantraniliprole 100SE plus Codacide oil: A field study to

evaluate residues in nectar and pollen in nectarine flowers in

Italy 2010 Eurofins Agroscience Services GmbH DuPont-


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.7.3/06 2011b DPX-HGW86 100OD plus Codacide oil: A field study to

evaluate residues in nectar and pollen in melon flowers at two

different locations in Spain 2009 Eurofins Agroscience

Services GmbH DuPont-27846, Revision No. 2 GLP: Yes

Published: No

Y Y FMC

IIA, 8.7.3/07 2011c Cyantraniliprole 200 g/L SC: A semi-field study to evaluate

effects on the honeybee (Apis mellifera; Hymenoptera,

Apidae) in melon in Spain 2010 Eurofins Agroscience

Services GmbH DuPont-29970 GLP: Yes Published: No

Y Y FMC

IIA, 8.7.3/08 2011d Cyantraniliprole 100 OD plus Codacide oil: A field study to

evaluate residues in pollen in tomato flowers in Spain 2010

eurofins-GAB GmbH DuPont-30545 GLP: Yes Published:

No

Y Y FMC

IIA, 8.7.3/09 2011e Cyantraniliprole 100SE: A field study to evaluate residues in

pollen in olive flowers in Spain 2010 eurofins-GAB GmbH


Y Y FMC

IIA, 8.7.3/10 2011f Cyantraniliprole 100 g/L OD: A field study to evaluate

residues in pollen and nectar in melon flowers in Italy 2010


No

Y Y FMC

IIA, 8.7.3/11 2011g Cyantraniliprole 100SE: A field study to evaluate residues in

pollen in olive flowers in Italy 2010 eurofins-GAB GmbH


Y Y FMC

IIA, 8.7.3/12 2011h Cyantraniliprole 100 g/L OD plus Codacide oil: A field study

to evaluate residues in pollen in tomato flowers in Italy 2010


No

Y Y FMC

IIA, 8.7.3/13 2011i Cyantraniliprole 100 g/L OD: A field study to evaluate

residues in pollen and nectar in melon flowers in Spain 2010


No

Y Y FMC

IIA, 8.7.3/14 2011j Cyantraniliprole 100SE plus Codacide oil: A field study to

evaluate residues in nectar and pollen in citrus flowers in

Italy 2010 eurofins-GAB GmbH DuPont-30029 GLP: Yes

Published: No

Y Y FMC

IIA, 8.7.3/15 2011k Cyantraniliprole 100SE plus Codacide oil: A field study to

evaluate residues in nectar and pollen in nectarine flowers in

Spain 2010 eurofins-GAB GmbH DuPont-30026, Revision


Y Y FMC

IIA, 8.7.3/16 2011L DPX-HGW86 100SE plus Codacide oil: A field study to

evaluate residues in nectar and pollen in apple flowers at two



Published: No

Y Y FMC

IIA, 8.7.3/17 2011m Cyantraniliprole 100SE plus Codacide oil: A field study to

evaluate residues in nectar and pollen in citrus flowers in

Spain 2010 eurofins-GAB GmbH DuPont-30028, Revision


Y Y FMC

IIA, 8.7.3/18 2011n DPX-HGW86 100OD plus Codacide oil: A field study to

evaluate residues in nectar and pollen in winter oilseed rape

flowers at two different locations in Spain 2009 eurofins-

GAB GmbH DuPont-27845, Revision No.2 GLP: Yes

Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.7.3/19 2011o DPX-HGW86 200SC: A semi-field study to determine

residues in nectar and pollen from foraging honey beeds

(Apis mellifera; Hymenoptera, Apidae), residues in fresh

honey, pollen and wax combs after exposure of the honey

bees to drip-irrigated melon in Spain 2009 Eurofins

Agroscience Services GmbH DuPont-27903, Revision No. 2


Y Y FMC

IIA, 8.7.3/20 2011q Cyantraniliprole 100SE plus Codacide oil: A laboratory study

to evaluate residues in nectar in citrus flowers collected in

study S09-00518 in Spain 2009 eurofins-GAB GmbH


Y Y FMC

IIA, 8.7.3/21 2011r DPX-HGW86 100SE plus Codacide oil: A field study to

evaluate residues in nectar and pollen in citrus flowers at two



Published: No

Y Y FMC

IIA, 8.7.3/22 2007 The translocation of [14C]DPX-HGW86 into pollen and

stamens of sunflower, canola, tomatoes and zucchini Charles


Published: No

Y Y FMC

IIA, 8.7.3/23 2009 The translocation of [14C]DPX-HGW86 into pollen and

stamens of Phacelia tanacetifolia Charles River Laboratories


Y Y FMC

IIA, 8.7.3/24 2006 DPX-HGW86 100 G/L OD: A semi-field study (non-GLP) to

evaluate effects on the honey bee (Apis mellifera carnica;

Hymenoptera, Apidae) in Phacelia in Germany 2006 Eurofins

Agroscience Services GmbH DuPont-19228 GLP: No

Published: No

N N FMC

IIA, 8.7.3/25 2009 DPX-HGW86 100 g/L OD: A semi-field study to evaluate

effects on the honey bee (Apis mellifera carnica;

Hymenoptera, Apidae) in Phacelia tanacetifolia in Germany

2008 Eurofins Agroscience Services GmbH DuPont-21984


Y Y FMC

IIA, 8.7.3/26 2010a DPX-HGW86 100 g/L OD plus Codacide oil: A semi-field

study to evaluate effects on the honey bee (Apis mellifera

carnica; Hymenoptera, Apidae) in Brassica napus in southern

Germany (Tubingen) 2009 Eurofins Agrosciences Services

GmbH DuPont-21318 GLP: Yes Published: No

Y Y FMC

IIA, 8.7.3/27 2010b DPX-HGW86 100 g/L OD plus Codacide oil and DPX-

HGW86 100 g/L SE plus Codacide oil: A semi-field study to

evaluate effects on the honey bee (Apis mellifera carnica;

Hymenoptera, Apidae) in Brassica napus in southern

Germany (Niefern) 2009 Eurofins Agroscience Services


Y Y FMC

IIA, 8.7.3/28 2011a DPX-HGW86 100 g/L SE plus Codacide oil: A field study to

evaluate residues in nectar and pollen in apple flowers at two

different locations in Germany 2009 Eurofins Agroscience


Y Y FMC

IIA, 8.7.3/29 2011b Cyantraniliprole 100 g/L OD: A field study to evaluate

residues in pollen of potato flowers in Germany 2010

Eurofins Agroscience Services GmbH DuPont-30546 GLP:

Yes Published: No

Y Y FMC

IIA, 8.7.3/30 2011c DPX-HGW86 100 g/L OD: A semi-field study to determine

residues in nectar and pollen from foraging honey bees (Apis

mellifera carnica; Hymenoptera, Apidae), residues in fresh

nectar, pollen and wax from combs and residues in plants and

flowers after exposure of the honey bees to treated Phacelia

tanacetifolia in Germany in 2008 Eurofins Agroscience


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.7.3/31 2011d DPX-HGW86 100 g/L OD plus Codacide oil: A study to

evaluate effects on the honey bee (Apis mellifera carnica) in

the field in Brassica napus L. following application after and

during bee-flight in southern Germany (Tubingen) in 2009


Yes Published: No

Y Y FMC

IIA, 8.7.3/32 2011e Cyantraniliprole 100 g/L OD: A field study to evaluate

residues in pollen of potato flowers in Italy 2010 Eurofins


Published: No

Y Y FMC

IIA, 8.7.3/33 2011f 100 g/L SE: Bee pollen residue - Cyantraniliprole 100 g/L

OD: A field study to evaluate residues in pollen and nectar in

grapevine flowers in Italy 2010grapes/Italy Eurofins


Published: No

Y Y FMC

IIA, 8.7.3/34 2011g Cyantraniliprole 100 g/L SE: A field study to evaluate

residues in pollen and nectar in grapevine flowers in

Germany 2010 Eurofins Agroscience Services GmbH


Y Y FMC

IIA, 8.7.3/35 2011h DPX-HGW86 100 g/L OD plus Codacide oil: A study to



during bee-flight in northern Germany (Celle) in 2009


Yes Published: No

Y Y FMC

IIA, 8.7.3/36 2011 Cyantraniliprole (DPX-HGW86) 100 g/L OD: A study to



during bee-flight in southern Germany (Tübingen) in 2010

and 2011 Eurofins Agroscience Services GmbH DuPont-

29572 Final GLP: Yes Published: No

Y Y FMC

IIA, 8.7.3/37 2011j DPX-HGW86 100 g/L OD plus Codacide oil: A study to



during bee-flight in northern Germany (Stade) in 2009


Yes Published: No

Y Y FMC

IIA, 8.7.3/38 2011k Cyantraniliprole (DPX-HGW86) 100 g/L OD plus Codacide

oil: A study to evaluate effects on the honey bee (Apis

mellifera carnica) in the field in Brassica napus L. following

application after and during bee-flight in northern France

(Alsace) in 2010 and 2011 Eurofins Agroscience Services

GmbH DuPont-29571 Final GLP: Yes Published: No

Y Y FMC

IIA, 8.7.3/39 2010 DPX-HGW86 100 g/L OD and DPX-HGW86 100 g/L OD

plus Codacide oil: A semi-field study to evaluate effects on

the honey bee (Apis mellifera carnica; Hymenoptera, Apidae)

in Phacelia tanacetifolia in South Germany 2010 Eurofins


Published: No

Y Y FMC

IIA, 8.7.3/40 2008a DPX-HGW86 100 g/L OD: A semi field study to evaluate

effects on the honey bee (Apis mellifer; Hymenoptera,

Apidae) on wheat treated with artificial honeydew in France

2008 Testapi DuPont-21705 GLP: Yes Published: No

Y Y FMC

IIA, 8.7.3/41 2008b DPX-HGW86 100 G/L OD: A semi field study to evaluate

effects on the honey bee (Apis mellifer; Hymenoptera,

Apidae) on phacelia in France 2008 Testapi DuPont-21706


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.7.3/42 2008 DPX-HGW86 100 g/L OD: Foliage residue toxicity to the

honeybee, Apis mellifera L. Wildlife International, Ltd.


Y Y FMC

IIA, 8.7.3/43 2010 Magnitude of cyantraniliprole and metabolite residues in

canola nectar and pollen following seed treatment with 625

g/L FS – NAFTA, 2009 ABC Laboratories, Inc. DuPont-


Y Y FMC

IIA, 8.7.3/44 2012 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus Codacide

Oil: A study to evaluate effects on the honeybee (Apis

mellifera) in the field in melon in Spain in 2011 Eurofins


Published: No

Y Y FMC

IIA,

8.8.1.1/01

2008a Cyantraniliprole (DPX-HGW86) 200 g/L SC: A laboratory

rate response test to evaluate the effects on the parasitoid

Aphidius rhopalosiphi (Hymenoptera, Braconidae) eurofins-


Y Y FMC

IIA,

8.8.1.1/02

2008b Cyantraniliprole (DPX-HGW86) 100 g/L OD: A laboratory

test to study the effects on the parasitoid Aphidius

rhopalosiphi (Hymenoptera, Braconidae) eurofins-GAB


Y Y FMC

IIA,

8.8.1.1/03

2009 DPX-HGW86 100 g/L SE: A laboratory rate response test to

evaluate the effects on the parasitoid Aphidius rhopalosiphi

(Hymenoptera, Braconidae) eurofins-GAB GmbH DuPont-


Y Y FMC

IIA,

8.8.1.2/01

2008a Cyantraniliprole (DPX-HGW86) 100 g/L OD: A laboratory

test to evaluate the effects on the predatory mite

Typhlodromus pyri (Acari, Phytoseiidae) eurofins-GAB


Y Y FMC

IIA,

8.8.1.2/02

2008b DPX-HGW86 200 g/L SC: A laboratory rate response test to

evaluate the effects on the predatory mite Typhlodromus pyri

(Acari, Phytoseiidae) eurofins-GAB GmbH DuPont-24249


Y Y FMC

IIA,

8.8.1.2/03

2009 Cyantraniliprole (DPX-HGW86) 100 g/L SE: A laboratory

rate response test to evaluate the effects on the predatory mite

Typhlodromus pyri (Acari, Phytoseiidae) eurofins-GAB


Y Y FMC

IIA,

8.8.2.1/01

2009 Cyantraniliprole (DPX-HGW86) 100 g/L SE plus Codacide

oil: An extended laboratory test with field-aged spray

deposits to study the effects on the aphid parasitoid, Aphidius

rhopalosiphi de Stefani Perez (Hymenoptera, Braconidae)


No

Y Y FMC

IIA,

8.8.2.1/02

2009a Cyantraniliprole (DPX-HGW86) 100 g/L SE + Codacide oil:

An extended laboratory test to evaluate the effects on the

parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae)

Institut für Biologische Analytik und Consulting IBACON


Y Y FMC

IIA,

8.8.2.1/03

2009b Cyantraniliprole (DPX-HGW86) 100 g/L OD: An extended

laboratory rate response test to study the effects on the

parasitoid Aphidius rhopalosiphi (Hymenoptera, Braconidae)



Y Y FMC

IIA,

8.8.2.1/04

2009c Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:

A semi-field test to evaluate the effects on the parasitoid,

Aphidius rhopalosiphi (Hymenoptera, Braconidae) Institut

für Biologische Analytik und Consulting IBACON GmbH


Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA,

8.8.2.1/05

2009d Cyantraniliprole (DPX-HGW86) 100 g/L SE + Codacide oil:





Y Y FMC

IIA,

8.8.2.1/06

2009e Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:



- aged residue test Institut für Biologische Analytik und

Consulting IBACON GmbH DuPont-27694 GLP: Yes

Published: No

Y Y FMC

IIA,

8.8.2.1/07

2010a Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:




GmbH DuPont-28801, Revision No. 1 GLP: Yes Published:

No

Y Y FMC

IIA,

8.8.2.1/08

2010b Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:

A laboratory test to evalute the effects on the mummies of the




Y Y FMC

IIA,

8.8.2.1/09

2010c Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil

or without Codacide oil: A semi-field test to evaluate the

effects on the parasitoid, Aphidius rhopalosiphi

(Hymenoptera, Braconidae) Institut für Biologische Analytik

und Consulting IBACON GmbH DuPont-29957 GLP: Yes

Published: No

Y Y FMC

IIA,

8.8.2.1/10

2010d Cyantraniliprole (DPX-HGW86) 100 g/L SE + Codacide oil:

A semi-field test to evalute the effects on the parasitoid,

Aphidius rhopalosiphi (Hymenoptera, Braconidae) Institut

für Biologische Analytik und Consulting IBACON GmbH


Y Y FMC

IIA,

8.8.2.2/01

2010a DPX-HGW86 100 g/L SE plus Codacide oil: A field study to

evaluate effects on predatory mites (Acari Phytoseiidae) in

apple orchards in Germany, 2009 eurofins-GAB GmbH


Y Y FMC

IIA,

8.8.2.2/02

2010b DPX-HGW86 100 g/L SE plus Codacide oil: A field study to

evaluate effects on predatory mites (Acari: Phytoseiidae) in

grape vinyards in Italy, 2009 eurofins-GAB GmbH DuPont-


Y Y FMC

IIA,

8.8.2.3/01

2010 Cyantraniliprole (DPX-HGW86) 200 g/L SC: An extended

laboratory test to study the effects on the rove beetle,

Aleochara bilineata (Coleoptera, Staphylinidae) Dr. U.

Noack-Laboratorien DuPont-26172 GLP: Yes Published: No

Y Y FMC

IIA,

8.8.2.3/02

2011 Cyantraniliprole (DPX-HGW86) 200 g/L SC: An extended

laboratory study to evaluate the effects on the staphylinid

beetle, Aleochara bilineata Gyll. - aged residue test -

IBACON DuPont-29908 GLP: Yes Published: No

Y Y FMC

IIA,

8.8.2.4/01

2010 Cyantraniliprole (DPX-HGW86) 200 g/L SC: Extended

laboratory test (dose-response-test) on Pardosa spp.

(Araneae, Lycosidae) Dr. U. Noack-Laboratorien DuPont-


Y Y FMC

IIA,

8.8.2.4/02

2009a Cyantraniliprole (DPX-HGW86) 100 g/L SE plus Codacide


deposits to study the effects on the green lacewing

Chrysoperla carnea steph. (Neuroptera, Chrysopidae)


No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA,

8.8.2.4/03

2009b Cyantraniliprole (DPX-HGW86) 100 g/L SE plus Codacide


deposits to study the effects on the ladybird beetle,

Coccinella septempunctata L. (Coleoptera, Coccinellidae)


No

Y Y FMC

IIA,

8.8.2.4/04

2009a Cyantraniliprole (DPX-HGW86) 100 g/L OD: An extended

laboratory rate response test to study the effects on the lady

bird beetle, Coccinella septempunctata (Coleoptera,

Coccinellidae) Institut für Biologische Analytik und


Published: No

Y Y FMC

IIA,

8.8.2.4/05

2009b Cyantraniliprole (DPX-HGW86) 100 g/L OD: An extended

laboratory rate response test to study the effects on the green

lacewing, Chrysoperla carnea steph. (chrysopidae,

neuroptera) Institut für Biologische Analytik und Consulting

IBACON GmbH DuPont-25525 GLP: Yes Published: No

Y Y FMC

IIA,

8.8.2.4/06

2009c Cyantraniliprole (DPX-HGW86) 100 g/L SE: An extended

laboratory test to evaluate the effects on the lacewing,

Chrysoperla carnea (Neuroptera: Chrysopidae) Institut für

Biologische Analytik und Consulting IBACON GmbH


Y Y FMC

IIA,

8.8.2.4/07

2009d Cyantraniliprole (DPX-HGW86) 100 g/L SE: An extended

laboratory test to evaluate the effects on the ladybird beetle,

Coccinella septempunctata (Coleoptera, Coccinellidae)



Y Y FMC

IIA,

8.8.2.4/08

2009e Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:


lacewing, Chrysoperla carnea (Neuroptera: Chrysopidae) -

aged residue test - Institut für Biologische Analytik und


Published: No

Y Y FMC

IIA,

8.8.2.4/09

2010f Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:


ladybird beetle, Coccinella septempunctata (Coleoptera,

Coccinellidae) - aged residue test - Institut für Biologische

Analytik und Consulting IBACON GmbH DuPont-28014,


Y Y FMC

IIA,

8.8.2.5/01

2010 Cyantraniliprole (DPX-HGW86) technical: Soil

microarthropod monitoring on plots of a litter bag study


Yes Published: No

Y Y FMC

IIA,

8.8.2.5/02

2011 Field study to evaluate the effects of cyantraniliprole on

collembola in Germany in 2010 Eurofins Agroscience

Services GmbH DuPont-29454 Final GLP: Yes Published:

No

Y Y FMC

IIA,

8.8.2.5/03

2009a IN-J9Z38: Effects on the collembola Folsomia candida in

artificial soil with 5% peat Institut für Biologische Analytik


Published: No

Y Y FMC

IIA,

8.8.2.5/04

2009b IN-K5A79: Effects on reproduction of the predatory mite

Hypoaspis aculeifer in artificial soil with 5% peat Institut für



Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA,

8.8.2.5/05

2009c Cyantraniliprole (DPX-HGW86) technical: Effects on

reproduction of the predatory mite Hypoaspis aculeifer in



Published: No

Y Y FMC

IIA,

8.8.2.5/06

2009d IN-PLT97: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/07

2009e IN-J9Z38: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/08

2009f IN-JCZ38: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/09

2010a IN-JCZ38: Effects on the collembola Folsomia candida in



Published: No

Y Y FMC

IIA,

8.8.2.5/10

2010b IN-K5A78: Effects on the collembola Folsomia candida in



Published: No

Y Y FMC

IIA,

8.8.2.5/11

2010c IN-PLT97: Effects on the collembola Folsomia candida in



Published: No

Y Y FMC

IIA,

8.8.2.5/12

2010d IN-JSE76: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/13

2010e IN-K5A78: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/14

2010f IN-JSE76: Effects on the collembola Folsomia candida in



Published: No

Y Y FMC

IIA,

8.8.2.5/15

2010g IN-K5A79: Effects on the collembola Folsomia candida in



Published: No

Y Y FMC

IIA,

8.8.2.5/16

2010h Cyantraniliprole (DPX-HGW86) technical: Effects on the

Collembola Folsomia candida in artificial soil with 5% peat



Y Y FMC

IIA,

8.8.2.5/17

2010i IN-K5A77: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/18

2010j IN-K5A77: Effects on the collembola Folsomia candida in



Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA,

8.8.2.5/19

2010k IN-QKV54: Effects on the collembola Folsomia candida in

artificial soil with 5% peat IBACON DuPont-29990 GLP:

Yes Published: No

Y Y FMC

IIA,

8.8.2.5/20

2010L IN-RNU71: Effects on the Collembola Folsomia candida in



Published: No

Y Y FMC

IIA,

8.8.2.5/21

2010m IN-J9Z38: Effects on the breakdown of organic matter in

litter bags in the field Institute für Biologische Analytik und


Published: No

Y Y FMC

IIA,

8.8.2.5/22

2010n QKV54: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/23

2010o RNU71: Effects on reproduction of the predatory mite




Y Y FMC

IIA,

8.8.2.5/24

2010p IN-K5A78: Effects on the breakdown of organic matter in

litter bags in the field Institut für Biologische Analytik und


Published: No

Y Y FMC

IIA,

8.8.2.5/25

2010q IN-K5A79: Effects on the breakdown of organic matter in



Published: No

Y Y FMC

IIA,

8.8.2.5/26

2010a Cyantraniliprole (DPX-HGW86) technical: Effects on the

decomposition of organic matter in the field Eurofins

Agroscience Services GmbH DuPont-28194, Revision No. 1


Y Y FMC

IIA,

8.8.2.5/27

2010b IN-JSE76: Effects on the decomposition of organic matter in

the field Eurofins Agroscience Services GmbH DuPont-


Y Y FMC

IIA,

8.8.2.5/28

2010c IN-PLT97: Effects on the decomposition of organic matter in

the field Eurofins Agroscience Services GmbH DuPont-


Y Y FMC

IIA,

8.8.2.5/29

2011 IN-K5A77: Effects on the breakdown of organic matter in



Published: No

Y Y FMC

IIA, 8.9.1/01 2008a IN-K5A78: Acute toxicity to the earthworm, Eisenia fetida,

in artificial soil International Institute of Biotechnology and


Y Y FMC

IIA, 8.9.1/02 2008b IN-K5A79: Acute toxicity to the earthworm, Eisenia fetida in

artificial soil International Institute of Biotechnology and


Y Y FMC

IIA, 8.9.1/03 2007a IN-J9Z38: Acute toxicity to the earthworm, Eisenia fetida in

artificial soil Institut für Biologische Analytik und Consulting


Y Y FMC

IIA, 8.9.1/04 2007b IN-JCZ38: Acute toxicity to the earthworm, Eisenia fetida in



Y Y FMC

IIA, 8.9.1/05 2007c IN-K5A77: Acute toxicity to the earthworm, Eisenia fetida in



Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.9.1/06 2008 DPX-HGW86 technical: Acute toxicity to the earthworm,

Eisenia fetida in artificial soil with 5% peat Institut für



Y Y FMC

IIA, 8.9.1/07 2008a IN-PLT97: Acute toxicity to the earthworm, Eisenia fetida in



Y Y FMC

IIA, 8.9.1/08 2008b IN-JSE76: Acute toxicity to the earthworm, Eisenia fetida in



Y Y FMC

IIA, 8.9.2/01 2010 IN-RNU71: Effects on reproduction and growth of the

earthworm, Eisenia fetida, in artificial soil with 5% peat



Y Y FMC

IIA, 8.9.2/02 2009a Cyantraniliprole (DPX-HGW86) technical: Effects on

reproduction and growth of the earthworm, Eisenia fetida, in



Published: No

Y Y FMC

IIA, 8.9.2/03 2009b IN-K5A77: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.9.2/04 2009c IN-JSE76: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.9.2/05 2009d IN-JCZ38: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.9.2/06 2009e IN-K5A78: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.9.2/07 2009f IN-K5A79: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.9.2/08 2009g IN-J9Z38: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.9.2/09 2009h IN-PLT97: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.9.2/10 2010 IN-QKV54: Effects on reproduction and growth of the




Y Y FMC

IIA, 8.10.1/01 2008a IN-K5A78: Assessment of the effects on soil microflora



Y Y FMC

IIA, 8.10.1/02 2008b IN-K5A79: Assessment of the effects on soil microflora



Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.10.1/03 2008c IN-PLT97: Assessment of the effects on soil microflora



Y Y FMC

IIA, 8.10.1/04 2008d IN-JSE76: Assessment of the effects on soil microflora



Y Y FMC

IIA, 8.10.1/05 2008e Cyantraniliprole (cyantraniliprole) technical assessment of

the effects on soil microflora Institut für Biologische

Analytik und Consulting IBACON GmbH DuPont-24874


Y Y FMC

IIA, 8.10.1/06 2010a IN-QKV54: Assessment of the effects on soil microflora



Y Y FMC

IIA, 8.10.1/07 2010b IN-RNU71: Assessment of the effects on soil microflora



Y Y FMC

IIA, 8.10.1/08 2007a IN-J9Z38: Assessment of the effects on soil microflora


No

Y Y FMC

IIA, 8.10.1/09 2007b IN-JCZ38: Assessment of the effects on soil microflora


No

Y Y FMC

IIA, 8.10.1/10 2007c IN-K5A77: Assessment of the effects on soil microflora


No

Y Y FMC

IIA, 8.12/01 2010a Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:

A greenhouse study to investigate the effects on seedling

emergence and growth of ten terrestrial plants following soil

exposure Wildlife International, Ltd. DuPont-29049 GLP:

Yes Published: No

Y Y FMC

IIA, 8.12/02 2010b Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:

A greenhouse study to investigate the effects on vegetative

vigor of ten terresterial plants following foliar exposure


Published: No

Y Y FMC

IIA, 8.12/03 2009a Cyantraniliprole (DPX-HGW86) 100 g/L OD: A greenhouse

study to investigate the effects on vegetative vigor of ten

terrestrial plants following foliar exposure Wildlife


Y Y FMC

IIA, 8.12/04 2009b Cyantraniliprole (DPX-HGW86) 100 g/L OD: A greenhouse

study to investigate the effects on seedling emergence and

growth of ten terrestrial plants following soil exposure


Published: No

Y Y FMC

IIA, 8.15/01 2010 DPX-HGW86 technical: Activated sludge, respiration

inhibition test Institut für Biologische Analytik und

Consulting IBACON GmbH DuPont-21473, Revision No. 1


Y Y FMC

IIA, 8.16.1/01 2012 Biological activity of cyantraniliprole and related metabolites

on selected insect species under laboratory conditions DuPont

Stine-Haskell Research Center DuPont-30351, Revision No.


N Y FMC

IIA, 8.7.1/10 2011 IN-DBC80: Acute oral toxicity to the honey bee, Apis

mellifera L. International Institute of Biotechnology and

Toxicology (IIBAT). DuPont-32968 GLP: Yes Published: No

Y Y FMC

Benevia Part A


15569 N


Annex point




Owner

IIA, 8.1.1/01 2008 DPX-HGW86 technical: An acute oral toxicity study with the



Y Y FMC

IIA, 8.1.1/02 2009 Cyantraniliprole technical: An acute oral toxicity study with

the zebra finch (Poephila guttata) Wildlife International, Ltd.


Y Y FMC




Y Y FMC



Published: No

Y Y FMC

IIA, 8.1.4/01 2008a DPX-HGW86 technical: A reproduction study with the


Published: No

Y Y FMC

IIA, 8.1.4/02 2008b DPX-HGW86 technical: A reproduction study with the



Y Y FMC

IIA,

8.2.1.1/01


with rainbow trout, Oncorhynchus mykiss DuPont Haskell


Y Y FMC

IIA,

8.2.1.2/01

2009a Cyantraniliprole (DPX-HGW86) technical: A 96-hour flow-

through acute toxicity test with the channel catfish (Ictalurus

punctatus) Wildlife International, Ltd. DuPont-19167 GLP:

Yes Published: No

Y Y FMC

IIA,

8.2.1.2/02

2009b Cyantraniliprole technical: A 96-hour flow-through acute

toxicity test with the sheepshead minnow (Cyprinodon


Yes Published: No

Y Y FMC

IIA,

8.2.1.2/03

2006 DPX-HGW86 technical: Static-renewal, acute, 96-hour

toxicity test to bluegill sunfish, Lepomis macrochirus DuPont


Y Y FMC

IIA, 8.2.4/01 2009 Cyantraniliprole (DPX-HGW86) technical: An early life-

stage toxicity test with the sheepshead minnow (Cyprinodon


Yes Published: No

Y Y FMC

IIA, 8.2.4/02 2007 DPX-HGW86 technical: Early life-stage toxicity to rainbow

trout, Oncorhynchus mykiss DuPont Haskell Laboratories


Y Y FMC

IIA,

8.2.6.1/01

2010 14C-DPX-HGW86: Bioconcentration in bluegill sunfish,

Lepomis macrochirus ABC Laboratories, Inc. DuPont-21985


Y Y FMC

Documents

HET COLLEGE VOOR DE TOELATING VAN ......van deel A van het registratierapport. 1.4 Aflever- en opgebruiktermijn (respijtperiode) Niet van toepassing. Het betreft een nieuwe toelating